Medical device for joining materials

ABSTRACT

A medical device for joining materials is provided. The device comprises a piercing element configured to penetrate materials to be joined. The piercing element is sufficiently sharp to penetrate materials to be joined and comprises a hollow interior along at least a portion of its length configured to distal advancement of a fastener therethrough; and an open tip through which the fastener can be pushed. The device can be used for fastening materials including tissue, synthetic mesh, and biologic mesh (e.g., ADM).

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication Nos. 62/926,273 filed on Oct. 25, 2019 and 63/022,286, filedMay 8, 2020.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety to the sameextent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

FIELD

This application relates to the field of surgical fastening devices.

BACKGROUND

Joining soft tissues and soft tissues to materials (such as synthetic,biological or resorbable mesh) is performed in many surgical proceduresand is typically accomplished using sutures, staples or tacks. However,these fixation methods come with tradeoffs. Placing multiple suturestakes a lot of time. Stapling and tacking can be relatively fast; but,they can be undesirable if metal or rigid, sharp-tipped fastenerspresent issues (e.g. pain, imaging, perforating structures, retention).Additionally, most existing staplers and tackers are unsuitable fortougher materials such as acellular dermal matrix (also known as ADM, abiological mesh), and require time-consuming suturing.

Acellular dermal matrix (ADM) is a material that is made from donorskin, typically of human or porcine origin, and processed to remove thecellular contents and preserve the collagen and elastin fiber matrix.ADM is used to treat a range of conditions where intact dermalscaffolding is needed and is approximated to tissue using suture.Examples of surgical procedures that use ADM include breastreconstruction, cosmetic breast procedures, abdominal wall repair (e.g.ventral/incisional hernia repair, wall reinforcement/prophylaxis), burnsand wounds (e.g. diabetic foot ulcers), and orthopedic procedures (e.g.quadriceps tendon reinforcement, Achilles tendon repair, andaugmentation in shoulder, hip and knee).

Currently there are no staplers that can penetrate ADM, so doctors usesutures to fix ADM to tissue, which is a time-consuming procedure. Inprocedures with other materials where staplers can be used (e.g. withmesh), doctors push the stapler into tissue using a good amount of forceto ensure a good connection. The pushing, however, risks damagingunderlying tissues or organs, as it causes the tissues to be stapled toabut underlying tissues during the stapling.

As an example, in ventral and incisional hernia repair, mesh is used toreinforce the midline closure to prevent hernia recurrence. If ADM isused in an open onlay approach, as shown in FIG. 1 , the ADM 2 is placedon the abdominal muscles 4 and sutured in place. Multiple sutures 6 arecarefully placed to fix the ADM 2 to muscle 4 so that the ADM 2 is taut,lays flat and has enough fixation points. Suturing is not onlytime-consuming, but also relatively difficult and technique dependent,which could negatively affect clinical outcomes.

A fast, easy to use fastener device that can pierce ADM or other mesh,facilitate ADM (or other mesh) positioning and tensioning, fix ADM (orother mesh) to soft tissue using a non-metal (polymeric or resorbable)fastener, and work with onlay procedures would be an advantageous toolthat reduces the surgeon's workload/procedure time and provides arepeatable fixation construct.

SUMMARY OF THE DISCLOSURE

In a first aspect, a fastening device is provided. The device comprisesa shaft; a handle; a needle extending from the shaft, the needlecomprising a slot extending along at least a portion of the needle. Thedevice can be configured to receive a fastener comprising a first barand a second bar connected by a bar connector, the first bar positionedwithin the needle and the second bar positioned outside the needle.

The device can further comprise at least one fastener comprising a firstbar and a second bar connected by a bar connector, the first barpositioned within the needle and the second bar positioned outside theneedle; and a push member configured to push the fastener out of theneedle.

The device can further comprise a push member configured to push thefastener out of the needle.

In some embodiments, the device further comprises a fastener reservoirwithin the shaft. The second bar can be positioned within the shaft. Insome embodiments, the device comprises at least one ramp near a distalend of the device, the ramp configured to reorient the second bar whilethe fastener is pushed distally. The device can comprise a shoulderpositioned at a fixed or adjustable distance proximal to the distal endof the needle. In some embodiments, the device comprises a triggerconfigured to deploy a fastener by engaging the push member. The shaftcan comprise one or more of an articulating end and a rotating end. Insome embodiments, the shaft comprises a bent end.

The shaft can comprise a replaceable cartridge. The replaceablecartridge can comprise the entire shaft or a distal portion of theshaft.

In some embodiments, the needle can be retracted and/or advancedrelative to the shaft. A distal portion of the shaft can be retractedand/or advanced relative to the needle.

In some embodiments, the needle comprises one or more barbs. The barbscan be ejectable/retractable. In some embodiments, the needle compriseson or more bumps. The needle can comprise one or more notches. In someembodiments, the needle comprises an area of enlarged diameter proximalto an end of the needle.

The needle can comprise one or more blades. The one or more blades canbe retractable. The one or more blades can be actuated. In someembodiments, the device comprises one or more auxiliary needles.

The one or more auxiliary needles can comprise one or more auxiliaryneedle barbs. In some embodiments, the one or more auxiliary needlebarbs are ejectable/retractable.

The device can comprise a first ramp extending from a surface close tothe needle, the first ramp extending away from the surface andconfigured to lift the bar connector and second bar above the needle asthe fastener is being pushed distally. In some embodiments, the devicecomprises a ramp extending from a sidewall, the ramp extending away fromthe sidewall and configured to rotate the second bar as the fastener isbeing pushed distally, such that the second bar is moved towards anorientation approximately parallel to a material being fastened. Thedevice can comprise a surface or sidewall configured to maintain therotated position of the second bar.

In some embodiments, at least a portion of the needle's slot is in ahelical shape. The device can comprise a support configured to providecountertraction to materials being fastened while the needle iswithdrawn from the materials.

The device can comprise a support configured to provide countertractionto materials being fastened while the needle is withdrawn from thematerials.

In some embodiments, the needle is bent or curved.

A width of the needle slot can be larger than a width of the barconnector or the fastener. In some embodiments, edges of the needle slotcomprise rounded, broken, polished, or other non-sharp edgeconfigurations.

A size of an inner diameter of the needle and a size of an outerdiameter of the needle can be selected to provide a sufficiently sizedpassageway through the material to be joined so the fastener's bar andbar connector pass through the material to be joined with minimal force.In some embodiments, the size of the inner diameter and outer diameterof the needle is selected to provide minimal insertion force in thematerial to be joined.

The bevel angle of the needle tip can be configured to provide minimalinsertion force in the material to be joined. In some embodiments, thebevel angle of the needle tip is configured to withstand repeated use.

A length of the needle can be selected to minimize trauma to tissue andstructures surrounding a repair site. In some embodiments, the length ofthe needle is selected to be suitable for depositing one end or morethan one end of the fastener in tissue.

In another aspect, a tissue fastener configured for joining tissue toanother material or tissue is provided. The fastener comprises a firstbar; a second bar; and a connector joining the first bar to the secondbar, wherein the connector is configured to be strong enough towithstand the deployment of the first bar.

In some embodiments, at least one of the first and second bar has one ormore blunt ends. At least one of a height, length, or width of thesecond bar can be different from a corresponding dimension of the firstbar. In some embodiments, the second bar is configured to flex. At leastone of the first bar and the second bar can be curved.

In some embodiments, at least one of the second bar and the first barcomprises downward and/or upward facing protrusions. At least one of thefirst bar, the second bar and the connector bar can comprise one or morebarbs. In some embodiments, at least one of the first bar and the secondbar comprises expanding wings. At least one of the first bar and thesecond bar can comprise curling arms.

In some embodiments, the first bar comprises a circular cross section.At least one of the first bar, the second bar, and the connector cancomprise a circular, ovular, square or rectangular cross section.

In some embodiments, a thickness or diameter of the connector is smallerthan a thickness or diameter of the first bar or second bar.

In some embodiments, the connector material is stretched orprestretched. The first arm and the second arm can extend in differentdirections. In some embodiments, at least one of the first bar and thesecond bar comprises an end feature. At least one of the first bar andthe second bar can comprise a bend. In some embodiments, a length of theconnector is adjustable. The connector can be positioned at an angleother than perpendicular relative to the first bar and the second bar.In some embodiments, at least one of the first bar, the second bar andthe connector bar comprises one or more materials. The connector bar canbe bent or curved.

In some embodiments, a length of the tissue fastener is sized to embedone or more ends of the fastener in tissue. The one or more ends of thefastener that are embedded in tissue can comprise one or more featuresconfigured to resist pulling out of tissue.

In some embodiments, one or more ends of the fastener that are notembedded in tissue comprise one or more features configured to retain anonlay material.

In some embodiments, a method for fastening an onlay material to tissueis provided. The method comprises piercing the onlay material and tissuewith a needle comprising a slot, the needle forming part of a fasteningdevice; and advancing a fastener comprising a first bar positionedwithin the needle, the first bar connected to a second bar by aconnector.

The method can comprise using a stop to control the insertion depth ofthe needle.

In some embodiments, the method comprises withdrawing the needle out ofthe tissue from a first location in tissue, positioning or tensioningthe material on the needle, and piercing the tissue at a secondlocation.

In some embodiments, the method comprises reorienting the second bar.

The method can comprise advancing the fastener comprising activating atrigger on the fastening device. In some embodiments, the methodcomprises maintaining/stabilizing the position of the needle within theonlay material and tissue while deploying the fastener.

The method can comprise reorienting the second bar comprises using oneor more ramps positioned near a distal end of the device. In someembodiments, reorienting the second bar comprises moving or lifting thesecond bar to avoid engaging the slot of the needle. Reorienting thesecond bar can comprise moving the second bar towards a positionparallel to a surface of the onlay material. In some embodiments,reorienting the second bar comprises rotating the second bar such thatthe second bar moves towards being parallel to the surface of the onlaymaterial.

In some embodiments, the method comprises deploying the first bar withinthe tissue. The method can comprise deploying the second bar such thatit rests adjacent to the onlay material. In some embodiments, the methodcomprises deploying the fastener such that the tissue and onlay materialare approximated and fixed together by the fastener. The method cancomprise withdrawing the needle from the onlay material and tissue afterthe fastener is deployed. In some embodiments, the method comprisessupporting the onlay material and tissue while withdrawing the needle.The method can comprise holding the onlay material and tissue away fromunderlying structures while the fastener is deployed.

In another aspect, a fastening device is provided. The device comprisestwo needles extending from the device, each needle comprising a slotextending along at least a portion of the needle; at least one fastenercomprising a first bar and a second bar connected by a bar connector;the first bar positioned within one needle and the second bar positionedwithin the other needle; and push members configured to push the barsdistally within and out of the needles.

In yet another aspect, a method for fastening an onlay material totissue is provided. The method comprises piercing the onlay material andtissue with two needles, each needle comprising a slot, the needlesforming part of a fastening device; advancing a fastener comprising afirst bar positioned within one needle, a second bar positioned withinthe other needle, the first bar connected to a second bar by aconnector; and deploying the first and second bars in tissue such thatthe tissue and onlay material are approximated and fixed together by thefastener.

In still another aspect, a fastening device is provided. The devicecomprises a needle extending from the device, the needle comprising aslot extending along at least a portion of the needle; at least onefastener comprising a first bar and a second bar connected by a barconnector, the first bar and second bar positioned within the needle;and a push member configured to push the bars distally within and out ofthe needle.

In another aspect, a method for fastening an onlay material to tissue isprovided. The method comprises piercing the onlay material and tissuewith a needle comprising a slot, the needle forming part of a fasteningdevice; advancing a fastener comprising a first bar and second barpositioned within the needle, the first bar connected to a second bar bya connector; deploying the first bar in tissue at a first location;removing the needle from the onlay material and tissue at the firstlocation; and deploying the second bar in tissue at a second locationsuch that the tissue and onlay material are approximated and fixedtogether by the fastener.

In yet another aspect, a fastening device is provided. The devicecomprises a first jaw comprising a needle comprising a slot; and asecond jaw, opposing the first jaw.

The device can comprise an opening configured to receive the needle whenthe first jaw and second jaw are moved towards one another.

In a further aspect, a method for fastening tissues or materials isprovided. The method comprises piercing a first tissue or material witha needle comprising a slot, the needle forming part of a fasteningdevice, wherein piercing the first tissue or material comprises movingopposing jaws of the fastening device towards one another; piercing asecond tissue or material with the needle and approximating the firstand second tissues or materials, wherein piercing the second tissue ormaterial comprises moving the opposing jaws towards one another; andadvancing a fastener comprising a first bar positioned within theneedle, the first bar connected to a second bar by a connector.

In some embodiments, the method comprises deploying the first barthrough the tissues or materials such that the first bar rests on thesurface of one of the tissues or materials and the second bar rests onthe surface of another of the other tissues or materials. The method cancomprise deploying the fastener such that the tissues or materials areapproximated and fixed together by the fastener.

In another aspect, a method for fastening tissues or materials isprovided. The method comprises piercing a first tissue or material witha first needle comprising a slot, the first needle forming part of thefastening device; piercing a second tissue or material with a secondneedle comprising a slot, the second needle forming part of thefastening device; approximating the first and second tissues ormaterials, wherein approximating the tissues or materials comprisesmoving the first tissue or material using the first needle, and piercingthe second tissue or material with the second needle; advancing thefastener comprising a first bar positioned within the first needle, asecond bar positioned within the second needle, the first bar connectedto a second bar by a connector; and deploying the first bar and secondbars through the tissues or materials such that the tissues or materialsare approximated and fixed together by the fastener.

In yet another aspect, a method for fastening an onlay material totissue is provided. The method comprises placing an onlay materialadjacent to the tissue; embedding a first bar of a fastener in thetissue; and positioning a second bar of the fastener adjacent to theonlay material, thereby fixing the onlay material to the tissue, whereinthe fastener comprises a connector joining the first bar to the secondbar.

In another aspect, a method for fastening a material to tissue isprovided. The method comprises placing a material adjacent to thetissue; placing a first bar of a fastener adjacent to the tissue; andplacing a second bar of the fastener adjacent to the material, therebyfixing the material to the tissue, wherein the fastener comprises aconnector joining the first bar to the second bar.

In a first aspect, a surgical device for joining materials is provided.The device comprises a head portion, a first and second fang comprisingsharp ends and a hollow or partially hollow interior; and a deploymentmember configured to push a staple out of the head portion.

The first fang can be configured to receive a first leg of a staple; anda second fang configured to receive a second leg of a staple. The devicecan also comprise a retractable backstop configured to be actuatedtowards the first and second fangs, comprising a first hole or partialperimeter configured to receive the first fang; and a second hole orpartial perimeter configured to receive the second fang; and a jointconnecting the head portion and retractable backstop and configured toenable retractable backstop to actuate towards the head portion.

In some embodiments, at least one of the first and second fangscomprises an open side shaped to allow passage of a staple leg. The openside can comprise a slot. The deployment member can comprise two outerdies configured to be moved down towards a center die. In someembodiments, the deployment member comprises a center die and two outerdies configured to be moved down towards the center die. At least one ofthe first and second fangs can comprise an angled or sharpened tip.

In some embodiments, the fangs can be attached to a retractable shuttle.The device can comprise a staple positioned in a retractable shuttlewith a first staple leg positioned within the first fang and a secondstaple leg positioned within the second fang. In some embodiments, theretractable shuttle is configured to retract the fangs.

In some embodiments, the device comprises a staple positioned in theretractable head with a first leg positioned within the first fang and asecond leg positioned within the second fang. The retractable head canbe configured to be retracted while the head portion maintains itsposition. The head portion can be configured to hold a plurality ofstaples. In some embodiments, the head portion comprises a staplecartridge configured to hold a plurality of staples.

In some embodiments, the head portion is on an end of a shaft. The headportion can be configured to rotate or articulate.

One or more fangs can comprise an attached blade. In some embodiments,one or more fangs comprises an actuatable blade. The blade can taperfrom a base of the fang toward an end of the fang. In some embodiments,one or more fangs is configured to articulate. One or more fangs cancomprise internal features shaped to guide the staple into a closedposition. In some embodiments, the one or more fangs is adjustable. Theone or more fangs can comprise threads. In some embodiments, wherein oneor more fangs comprises at least one of a barb, notch or neck. The fangscan be replaceable. In some embodiments, the fangs are covered by anactuatable shroud or backstop.

In another aspect, a surgical device for joining materials is provided.The device comprises a head portion comprising a fang and a deploymentmember configured to push the staple out of the head portion.

The fang can be configured to receive legs of the staple.

The device can comprise a retractable backstop configured to be actuatedtowards the fang. The retractable backstop comprises a first hole orpartial perimeter configured to receive the fang and a joint connectingthe head portion and the retractable backstop and configured to actuatethe retractable backstop towards the fang.

In some embodiments, the head portion is configured to rotate at least180°. In some embodiments, the fang comprises an open side shaped toallow passage of a staple leg.

The head portion can be configured to articulate. In some embodiments,the first fang comprises a blade attached to it. The blade can taperfrom a base of the fang towards an end of the fang. In some embodiments,the fang is configured to articulate. The fang can comprise internalfeatures shaped to guide the staple into a closed position. In someembodiments, a position of the first fang is adjustable. The first fangcan be threaded. In some embodiments, the fang comprises at least one ofbarbs, notches, and necks. The fang can be replaceable. In someembodiments, the fang is configured to flip down from the head portion.

In yet another aspect, a method for joining materials is provided. Themethod comprises piercing a first material and a second material withfangs, the fangs forming part of a fastening device; and deploying astaple through the fangs.

The method can comprise first piercing the first material with thefangs. The method can comprise first piercing only the first materialwith the fangs by positioning the first material between the fang andbackstop, moving the backstop toward the fangs thereby pushing the firstmaterial onto the fangs. In some embodiments, the method comprisescomprising moving the backstop away from the fangs and retracting thebackstop. The method can comprise positioning the first material to thesecond material using the fangs to which the first material is attached.The method can comprise piercing the second material with the fangs. Insome embodiments, the method comprises retracting the first and secondmaterials using one or more of the fangs or partially deployed staple.The method can comprise deploying the staple to join the first materialto the second material. In some embodiments, the method comprisesremoving the fangs from the first and second materials. The method cancomprise comprising deploying the staple by pushing the staple out ofthe head portion. In some embodiments, the method comprises deployingthe staple by forming the staple around a center die. The method cancomprise deploying the staple using outer dies to form the staple arounda center die. The first material can comprise an onlay material. Thesecond material can comprise tissue.

In another aspect, a surgical device for joining materials is provided.The device comprises a head portion, comprising a first staple exitconfigured to allow passage of a first staple leg; a second staple exitconfigured to allow passage of a second staple leg; and a deploymentmember configured to push a staple out of the head portion.

The device can also comprise a retractable backstop configured to beactuated towards the staple legs, comprising a first hole or partialperimeter configured to receive the first staple leg; and a second holeor partial perimeter configured to receive the second staple leg; and ajoint connecting the head portion and retractable backstop andconfigured to enable the retractable backstop to actuate towards thestaple legs.

In some embodiments, the deployment member comprises a center die andtwo outer dies configured to be moved down towards the center die.

In some embodiments, the first and second staple legs comprise angled orsharpened tips.

The device can comprise a staple that can be positioned in a retractableshuttle. In some embodiments, the device comprises a staple positionedin a retractable shuttle with the first staple leg positioned at or inthe first staple exit and a second staple leg positioned at or in thesecond staple exit. The retractable shuttle can be configured to retractthe staple legs.

The head portion can comprise a staple cartridge configured to hold aplurality of staples. The head portion can comprise a staple cartridgeconfigured to hold a plurality of staples. The head portion can be on anend of a shaft. The head portion can be configured to rotate orarticulate. The head portion can comprise one or more attached blades.The head portion can comprise one or more actuatable blades. The bladecan taper from the base of the head portion toward and end of the stapleleg. The staple legs can be configured to flip down from the head. Thestaple legs can be covered by an actuatable shroud or backstop.

In another aspect, a surgical device for joining materials is provided.The device comprises a first arm, comprising a channel configured forholding a staple; an opening in the channel to allow passage of thestaple during staple deployment; and a push member configured to advancethe staple out of the first hole. The device also comprises a second armcomprising a second hole or partial perimeter; and a hinge connectingfirst arm and second arm and configured to allow the first arm andsecond arm to be moved away from each other and to be moved towards oneanother.

The first arm can comprise a stop configured to interact with a formedfeature of the staple to arrest motion of the staple. The stop can beconfigured to disengage.

In some embodiments, the first arm comprises a first forming memberconfigured to form the staple. In some embodiments, the first armcomprises a moveable second forming element configured to advance andwork in conjunction with the first forming element to form the staple.In some embodiments, the second arm comprising a hole or portion of aperimeter (such as a slot) moves toward the first arm to receive thepiercing end of the staple. In some embodiments, the first arm comprisesa push member configured to push the staple. The first arm can comprisea push member configured to push the staple through forming elements toform the staple. In some embodiments, the staple has a first preformedend configured to pierce the materials to be joined. The staple can havea second preformed end configured to interact with the stop and retain amaterial to be joined.

In another aspect, a method of joining materials is provided. The methodcomprises moving opposing arms or jaws towards one another to pierce thematerials to be joined with an end of a staple; securing the materialsto be joined between the opposing arms or jaws; and deploying andforming the staple to fix the materials to be joined.

The method can comprise advancing a first end of the staple out of achannel opening in the first arm or jaw. In some embodiments, the methodcomprises advancing a second forming element to shape a first end of thestaple for piercing materials to be joined. The method can compriseusing a stop to interact with a formed feature of the staple to arrestmotion of the staple during the advancement of the second formingfeature.

In some embodiments, the method comprises positioning a first materialof the materials between the opposing arms or jaws. The method cancomprise moving the opposing arms or jaws towards one another to piercethe first material on the staple. The method can comprise moving theopposing arms away from one another. The method can comprise furthercomprising positioning a second material of the materials between theopposing arms or jaw.

The method can comprise moving the opposing arms or jaws towards oneanother to pierce the second material on the staple. The method cancomprise securing the materials to be joined between the opposing armsor jaws. In some embodiments, the method comprises pushing the staplethrough one or more forming members to fully form and close the staple,fixing the materials together. The method can comprise releasing thestaple from the first arm or jaw, leaving the materials fixed togetherby the staple. The method can comprise moving the opposing arms or jawsaway from one another to release the materials.

In another aspect, a tissue fastener or staple configured for joiningtissue to another material or tissue is provided. The fastener or staplecomprises a first leg; a second leg; and a span connecting the first legand second leg. The first leg and second leg can be approximatelyperpendicular to the span. In some embodiments, the first leg and secondleg have an acute angle to the span. In some embodiments, the bendbetween the span and the legs comprises bend radius of about0.005-0.020″. In some embodiments, the bend between the span and thelegs comprises a bend radius of about 0.021-0.100″. In some embodiments,ends of the closed staple legs reside relatively in the same plane aboveand below each other. In some embodiments, the span is configured withbumps or humps on the lateral aspects of the span. The fastener cancomprise a metal, a polymer, and/or a resorbable material.

In another aspect, a tissue fastener or staple configured for joiningtissue and/or materials is provided. The staple comprises comprising oneor more preformed bends on a first end of the staple; and a sharpenedtip on a second end of the staple. In some embodiments, the one or morepreformed bends on the first end of the staple are configured to retainmaterials to be joined. In some embodiments, the sharpened tip on thesecond end of the staple is configured to pierce materials to be joined.In some embodiments, the second end of the staple comprises one or morepreformed bends. The fastener can comprise a metal, a polymer, and/or aresorbable material.

In another aspect, a tissue fastener or staple configured for joiningtissue and/or materials. The fastener comprises one or more heads on afirst end of the staple; and a sharpened tip on a second end of thestaple. The fastener can comprise a metal, a polymer, and/or aresorbable material.

In another aspect, a surgical device for joining materials is provided.The device comprises a moveable housing comprising a track; a pushmember configured to be advanced along the track; a first linkageconnected to the housing and a first articulating fang; and a secondlinkage connected to the housing and a second articulating fang.

In some embodiments, the fangs have sharpened tips configured to piercematerials to be joined. The articulating fangs can be configured torotate the fang tips toward each other.

The fangs can have internal grooves configured to guide a staple orfastener to be formed. The fangs can have internal grooves configured toform a staple. In some embodiments, the fangs have internal groovesconfigured to shield the staple from surrounding tissue and bodilystructures. The push member can be configured to have end features forpushing a staple or fastener to be formed. In some embodiments, thearticulating fangs are located at an end of a shaft.

In another aspect, a surgical device for joining materials is provided.The device comprises a first jaw; a second jaw, wherein the first jawand/or the second jaw are configured to be actuated towards one another;a hook positioned within the first jaw, an end of the hook extending uptowards the second jaw, the end of the hook configured to be deployedfrom the first jaw; and one or more staples positioned within the secondjaw and configured to be deployed in a direction towards the first jaw.

In some embodiments the second jaw comprises a window with a frame atleast partially surrounding the window on a side of the second jawfacing the first jaw. The hook can be rigid of flexible.

In another aspect, a method of joining materials is provided. The methodcomprises clamping a first material between the first jaw and the secondjaw of a device; deploying a hook from the first jaw to capture the andstabilize the first material to the first jaw; unclamping the first jawand the second jaw; positioning a second material adjacent to the firstmaterial and between the first jaw and the second jaw; clamping thematerials between the first jaw and the second jaw; and deploying astaple from the second jaw to join the first material and the secondmaterial.

In some embodiments, deploying a staple or fastener comprises deployinga staple or fastener from the second jaw. In some embodiments, deployinga staple or fastener comprises deploying a staple or fastener from thefirst jaw. The method can comprise retracting the hook from the firstmaterial.

In yet another aspect, a device for stabilizing materials is provided.The device comprises a first jaw comprising one or more piercingelements; a second jaw comprising one or more openings or recesses,wherein the first jaw and the second jaw, are configured to be movedtowards one another

In some embodiments, the one or more piercing elements positioned on thefirst jaw and extending towards the second jaw, are configured tointeract with the one or more openings or recesses on the second jawwhen the first jaw and second jaw are moved sufficiently towards oneanother. In some embodiments, the one or more piercing elementspositioned on the first jaw and extending towards the second jaw, isconfigured to enter the one or more openings or recesses on the secondjaw when the first jaw and second jaw are moved sufficiently towards oneanother.

In another aspect, a method for stabilizing materials to be joined isprovided. The method comprises positioning a first material between thefirst jaw and the second jaw of a device; moving the first jaw and thesecond jaw towards one another such that one or more piercing elementspositioned on the first jaw pierces the first material; separating thefirst jaw and the second jaw; positioning a second material between thefirst jaw and the second jaw; and moving the first jaw and the secondjaw towards one another such that one or more piercing elementspositioned on the first jaw pierces the second material.

In some embodiments, the method comprises moving the first jaw and thesecond jaw towards one another such that the one or more piercingelements positioned on the first jaw pierce material by entering the oneor more openings or recesses on the second jaw.

The method can comprise comprising moving or retracting the device tomove or retract the first and second materials. The method can compriseapproximating a stapling mechanism to the stabilized materials. Themethod can comprise stapling the first material and the second material.The method can comprise joining the first material and the secondmaterial using other joining means, such as suture, tacks, fasteners,glue, etc.

In another aspect, a device for stabilizing material to be surgicallystapled is provided. The device comprises a first jaw comprising a sharptip; and a second jaw comprising a sharp tip, wherein the first jawand/or second jaw is configured to be moved towards the other jaw.

In another aspect, a method for stabilizing materials to be joined isprovided. The method comprises positioning a first material between thefirst jaw and the second jaw of a device, the first and second jaws eachcomprising sharpened tips; moving the first jaw and the second jawtowards one another such that the sharp tips pierce the first material.

The method can comprise separating the first jaw and the second jawwhile keeping the first material on sharp tips, moving the first jaw andsecond jaw towards one another such that the sharp tips pierce thesecond material. The method can comprise moving or retracting the deviceto more or retract the first and second materials. The method cancomprise approximating a stapling mechanism to the stabilized materials.The method can comprise joining the first material and the secondmaterial using other joining means, such as suture, tacks, fasteners,glue, etc. In some embodiments, the method comprises stapling the firstmaterial to the second material.

In another aspect, a surgical device for joining materials is provided.The device comprises an elongate shaft; and a curved staple positionedat a distal end of the elongate shaft.

The staple can be positioned in a plane perpendicular to the elongateshaft. In some embodiments, the staple is positioned in a plane orientedat an angle other than perpendicular to the elongate shaft. A second armor shaft can comprise a slot or opening at its end configured to supportthe material and receive an end of the staple. The second arm or shaftcan be configured to actuate or rotate to form or close the staple.

In another aspect, a method for joining materials is provided. Themethod comprises advancing a device comprising an elongate shaft and acurved staple positioned at a distal end of the elongate shaft, thestaple positioned in a plane perpendicular to the elongate shaft to asurgical site; positioning a first material on a second material;rotating the elongate shaft such that a piercing end of the curvedstaple pierces the first material and the second material; and closingthe staple.

In some embodiments, an edge of the first material is joined to thesecond material. The method can comprise positioning a second arm orshaft comprising a slot or opening at the end to support the materialand receive the piercing end of the staple. The method can compriseactuating or rotating the second arm or shaft to form or close thestaple. The method can comprise comprising releasing the staple from thedevice. The method can comprise actuating or rotating of the elongateshaft to form or close the staple. At least one of the first and secondmaterials can comprise ADM.

In another aspect, a device for joining materials is provided. Thedevice comprises a first elongate shaft configured to hold a first legof a staple; a second elongate shaft configured to hold a second leg ofa staple, the first and second elongate shaft positioned adjacent to andsubstantially parallel to one another, wherein rotation of the elongateshafts causes the staple legs to move towards one another.

In some embodiments, the first and second staple legs are curved towardsone another.

In another aspect, a method of surgically stapling materials isprovided. The method comprises advancing a device to the surgical site,the device comprising a first elongate shaft comprising a first leg of astaple a second elongate shaft comprising a second leg of a staple;positioning a first material on a second material; and rotating thefirst and second elongate shafts relative to one another such that thefirst and second legs pierce the first and second materials and closethe staple.

In some embodiments, the method comprises releasing the staple from thedevice. In some embodiments, at least one of the first materials and thesecond materials comprises ADM.

In another aspect, a surgical device for joining materials is provided.The device comprises a first jaw configured to hold a first end of astaple, the first end of the staple comprising a preformed feature, andthe second end configured to pierce material; and a second jawcomprising a slot or opening, the first jaw and the second jawconfigured to move towards one another.

In some embodiments, the preformed feature comprises a loop or hookshape. In some embodiments, the slot or opening in the second jaw isconfigured to receive the second end of the staple when the first jawand second jaw are moved towards one another. In some embodiments, thesecond jaw is configured to actuate or rotate to form or close thestaple. In some embodiments, the second jaw is advanceable andretractable with respect to the first jaw. The second jaw can comprisean anvil. The first jaw can comprise an actuator configured to advancethe staple into the anvil on the second jaw. The second end of thestaple can comprise a bend. The first jaw can comprise a piercing shroudor fang configured to cover the staple tip.

In another aspect, a method for joining materials is provided. Themethod comprises advancing a device comprising a first jaw and a secondjaw, the first jaw holding a first end of a staple comprising apreformed feature; positioning a first material between the first jawand the second jaw; moving the first jaw and the second jaw towards oneanother such that a second end of the staple pierces the first materialand enters a slot or opening on the second jaw; moving the first jaw andthe second jaw away from one another; positioning a second materialbetween the first jaw and the second jaw; and moving the first jaw andsecond jaw towards one another, such that the second end of the staplepierces the second material.

The method can comprise moving the first material into the preformedfeature on the staple. The method can comprise moving or retracting thedevice to move or retract the first and second materials.

The method can comprise actuating or rotating the second jaw to closethe staple. In some embodiments, the method comprises sliding the secondjaw to align the staple tip with an anvil on the second jaw prior topositioning the second material. The method can comprise moving the jawstowards one another such that the second end of the staple pierces thesecond material, enters the anvil and curls, forms or closes the staple.The method can comprise releasing the staple from the device.

In another aspect, a staple configured to be used with any of thedevices or methods disclosed herein is provided. The staple comprises acentral portion; a first leg extending from a first end of the centralportion at a first bend; and a second leg extending from a second end ofthe central portion at a second bend, wherein the first bend and thesecond bend each comprise a hump.

In yet another aspect, a staple configured to be used with any of thedevices or methods disclosed herein is provided. The staple comprises afirst leg extending from a first end of the central portion at a firstintersection; and a second leg extending from a second end of thecentral portion at a second intersection, wherein the central portioncomprises at least one bump proximate to the intersections.

In another aspect, a device for joining materials is provided. Thedevice comprises a first arm comprising a first fang and a first hole; asecond arm comprising a second fang and a second hole, wherein the firstarm is connected to the second arm at a joint, and wherein the first armand the second arm are configured to rotate towards one another aboutthe joint, and wherein, when rotated, the first fang is configured toenter the second hole and the second fang is configured to enter thefirst hole. The fangs can comprise one or more of notches, barbs, ornecks, etc. to retain the first material on the fang. The fangs cancomprise a lubricious coating so the opposing fang can be removed fromthe first material.

In another aspect, a method for joining materials is provided. Themethod comprises advancing a device comprising a first arm comprising afirst fang and a first hole; and a second arm comprising a second fangand a second hole, the first arm and the second arm connected at andconfigured to rotate about a joint; positioning the device above a firstmaterial, the device in an open position; piercing the first materialwith the first and second fangs; rotating the first arm and the secondarm about the joint such that the first fang enters the second hole andthe second fang enters the first hole; rotating the first arm and thesecond arm away from one another; positioning the device and theattached first material over a second material; and piercing the secondmaterial with the first and second fangs.

The method can comprise deploying a staple to join the first and secondmaterials. The method can comprise moving or retracting the device tomove or retract the first and second materials.

In another aspect, a device for joining materials is provided. Thedevice comprises carriers configured to extend from a head, the headconfigured to deploy a staple; and sharp elements configured to extendfrom the carriers wherein tips of the sharp elements are configured tomove toward one another to grasp target materials, the carriersconfigured to retract while the sharp elements remain extended toapproximate the head to the target materials.

The tips of the sharp elements can be configured to overlap one anotherto grasp and/or pierce target materials. The sharp elements can beconfigured with surfaces that prevent the staple ends from protrudingpast the sharp elements.

In another aspect a prosthetic material comprising a plurality or arrayof holes is provided. The plurality or array of holes can be configuredfor a size that allows a staple or fastener, or portions of a staple orfastener, to pass through the material.

In another aspect, a device for joining materials is provided. Thedevice comprises a body comprising features for anchoring in bone; and awire extending from the body, forming an exposed end of the wire.

The exposed end of the wire can comprise a point.

The wire can be configured to bend in order to retain material ortissue.

In another aspect, a method for joining materials is provided. Themethod comprises inserting into bone one or more devices for joiningmaterials to bone, wherein the device comprises a body comprisingfeatures for anchoring in bone, and a wire extending from the body;piercing the one or more materials to be joined to bone using the wire;and forming or closing the wire to secure the one or more materials tobone.

In another aspect, a device for joining materials is provided. Thedevice comprises a fastener or staple in the shape of a loop comprisingat least one sharp end; a shaft configured to expand the loop of one ormore staples, wherein the shaft resides in the inner diameter of theloop of one or more staples and rotate and push on the end of one ormore staples.

The staple can be located at the end of the shaft is configured topierce the materials to be joined with the sharp end as staple isrotated by the shaft. In some embodiments, a diameter of the staple looprecovers or contracts to fix the materials to be joined.

In another aspect, a device for joining materials is provided. Thedevice comprises a polymer strand comprising a series of openings,wherein the openings are configured to receive and end of the polymerstrand and configured to melt and fuse the joint between the opening andstrand passed through the opening, creating a fixed loop.

The device can comprise a guide tube comprising a point configured topierce materials to be joined and form a loop shape; and a slot down alength or a portion of the length of the tube, wherein the slotted lumenof the guide tube is sized to allow the polymer strand with openings topass.

In another aspect, a device for joining materials is provided. Thedevice comprises a first curved tubular lumen with a point; and a secondcurved tubular lumen with a point, wherein the first and second curvedtubular lumens articulate to pierce a first and second material to bejoined and mate the opposing points of both tubular lumens to oneanother.

In some embodiments, the mated points of both tubular lumens create acontinuous lumen configured to receive a material, the continuous lumenforming a loop shape. The tubular lumens can be configured to beremoved, leaving the polymeric loop that approximates and fixes thematerials together.

In yet another aspect, a device for joining materials is provided. Thedevice comprises a curved cannula with a point on one end configured topierce materials to be joined and create a passageway through thematerials so a suture or strand can be passed through the materials. Insome embodiments, the curved cannula can be removed, leaving the sutureor strand in the materials to be joined. In some embodiments, a cinchingelement can cinch a loop with the suture or strand to approximate thematerials to be joined. In some embodiments, the cinching element orseparate element can fuse the loop In some embodiments, excess lengthsof the suture or strand can be removed, leaving a loop that fixes thematerials together.

In still another aspect, a device for stabilizing materials is provided.The device comprises an inner tube comprising angled barbs on one end;and an outer tube comprising angled bard on the same end, wherein anangled barb on the inner tube and an angled barb on the outer tube pointtoward each other creating a pair; and one or more pairs of barbs thatpinch or secure one or more materials to be joined when the inner orouter tube is rotated in a direction that brings the tips of one or morepairs of barbs together.

The inner tube can have a lumen through which instruments can be passed.In some embodiments, walls of the inner and outer tubes comprise windowsto provide visibility and access to a working area of stabilized tissue.

In another aspect, a device for stabilizing materials is provided. Thedevice comprises at least two pincers, wherein the tips of the pincerspoint toward one another and a portion of each pincer has an outwardprofile, a tube surrounding the pincers and configured to advance andbring tips of the pincers together. In some embodiments, the tips of thepincers are configured to grasp material when the tips of the pincersare moved toward one another.

In yet another aspect, a fastening device is provided. The devicecomprises a shaft; a needle extending from the shaft, the needlecomprising a slot extending along at least a portion of the needle; thedevice configured to receive at least one fastener comprising a firstbar and a second bar connected by a bar connector, the first barconfigured to be positioned within the needle and the second barconfigured to be positioned outside the needle; a push member configuredto push the fastener out of the needle; one or more control rodscomprising a connector, the connector configured for connection to asurgical robot.

In some embodiments, the shaft is configured to rotate and/orarticulate. In some embodiments, at least one control rod provides themotion for moving a fastener from a conveyance zone through a transitionzone. In some embodiments, at least one control rod is configured toprovide the motion for moving a fastener from a transition zone througha manipulation zone and deploying the fastener. One or more control rodconnectors can be configured for connection to one or more control rodsof the surgical robot. In some embodiments, the one or more control rodconnectors comprise a connection clamp or union configured to interactwith a ball or end feature on the surgical robot. In some embodiments,the connection clamp or union comprises a first position in the deviceto receive the ball or end feature on the surgical robot. In someembodiments, the connection clamp or union comprises a second positionin the device to secure the control rod connection to the surgicalrobot. In some embodiments, the connector on the fastening devicecomprises a collar that attaches to the surgical robot. In someembodiments, the connector on the fastening device threads onto thesurgical robot. In some embodiments, the device is configured to receivea fastener cartridge comprising one or more fasteners. The fastenercartridge can be replaceable. The fastener cartridge can be configuredfor replacement while the device remains connected to the surgicalrobot. In some embodiments, the fastener cartridge comprises features tosecure the cartridge to the device. The fastener cartridge can comprisespring loading features to secure the cartridge to the device. In someembodiments, the fastener cartridge comprises features that align thecartridge to a transition zone of the device. In some embodiments, thefastener cartridge comprises features that align the cartridge to thecontrol rods or push rods of the device. The fastener cartridge can beflexible. In some embodiments, the needle of the device is configuredfor replacement while the device remains connected to the surgicalrobot.

In another aspect, a fastening device configured for fixation in softtissue is provided. The device comprises one or more piercing elementscomprising a sharp tip and a hollow or partially hollow interior incommunication with an opening near or through the tip, wherein thehollow or partially hollow interior is configured to allow advancementof a fastener.

The device can comprise a push member configured to advance a fastener.In some embodiments, the device comprises a fastener configured toadvance along the interior of the piercing element and out of theopening near or through the tip. A length of the fastener can be sizedto allow embedding one or more ends of the fastener in tissue. In someembodiments, one or more ends of the fastener that are configured to beembedded in tissue comprise one or more features configured to resistpulling out of tissue. One or more ends of the fastener that are notembedded in tissue can comprise one or more features configured toretain an onlay material. In some embodiments, a length of the piercingelement is selected to minimize trauma to tissue and structuressurrounding a repair site. In some embodiments, a length of the piercingelement is selected to be suitable for depositing one end or more thanone end of the fastener in tissue.

In another aspect, a method for fixation in soft tissue is provided. Themethod comprises piercing a material to be joined using one or morepiercing elements of a fastening device; advancing a fastener along aninterior of the piercing element; and pushing the fastener out of anopening near or through a tip of the piercing element.

The method can comprise using a stop, shoulder, etc. that controls aninsertion depth of the piercing element(s). The method can comprisedepositing one end or more than one end of the fastener in tissue.

In another aspect, a method for fixation in soft tissue is provided. Themethod comprises piercing a material to be joined using one or morepiercing elements of a fastening device, wherein the piercing elementcreates one or more openings or passages through the material to bejoined.

The method can comprise pushing a fastener through the opening(s) orpassage(s) created by the one or more piercing elements in the materialto be joined. The method can comprise depositing one end or more thanone end of the fastener in tissue.

In another aspect, a device for fastening materials is provided. Thedevice comprises a piercing element configured to penetrate materials tobe joined, wherein the piercing element is sufficiently sharp topenetrate the materials, wherein the piercing element comprises a hollowinterior along at least a portion of its length, the hollow interiorconfigured for distal advancement of a fastener therethrough; and anopen tip through which the fastener can be pushed.

The device can comprise a push member to advance the fastener distallywithin and out of the piercing element. In some embodiments, a length ofthe piercing element can be selected to minimize and/or avoid trauma tosurrounding structures. In some embodiments, a length of the piercingelement can be selected to be suitable for depositing one end of thefastener in tissue. In some embodiments, the length of the piercingelement is about 0.100 in-0.380″. The piercing element can comprise aneedle or a fang.

In another aspect, a method for joining materials is provided. Themethod comprises inserting a piercing element of a fastening device intoor through a material; advancing a fastener along an interior of thepiercing element; pushing the fastener or a portion of the fastenerthrough the material and out of a distal tip of the piercing element.

In another aspect, a method for joining materials is provided. Themethod comprises inserting a piercing element of a fastening device intoa material creating one or more openings or passages through thematerial; and passing a fastener through the openings or passagescreated by the piercing element.

The material can comprise synthetic mesh, biologic mesh (e.g., ADM),and/or tissue.

In another aspect, a method for joining materials is provided. Themethod comprises inserting a piercing element of a fastening device intoa mesh; advancing a fastener along an interior of the piercing element;pushing the fastener or a portion of the fastener through the materialand out of a distal tip of the piercing element.

In another aspect, a method for joining materials is provided. Themethod comprises inserting a piercing element of a fastening device intoor through a mesh creating one or more openings or passages through thematerial; and passing a fastener through the openings or passagescreated by the piercing element.

The mesh can comprise a synthetic mesh and/or a biologic mesh.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 is a schematic of an onlay procedure.

FIG. 2 shows an embodiment of a fastener device.

FIGS. 4-9 show an embodiment of a method for using the device of FIG. 2in an onlay procedure.

FIG. 10 shows an embodiment of a fastener.

FIG. 11 shows an embodiment of a fastener positioned within a needle ofa fastening device.

FIGS. 12-15 show an embodiment of a method for using the fasteningdevice of FIG. 11 in an onlay procedure that includes an embodiment of adeflector that interacts with the fastener's filament.

FIGS. 16-19 show an embodiment of a method for using the fasteningdevice of FIG. 11 in an only procedure with clear materials to allowvisualization.

FIG. 20 shows an embodiment of a fastener comprising blunt ends.

FIG. 21 shows an embodiment of a fastener where the second bar has ashorter length L and different height H than the first bar.

FIG. 22 show an embodiment of a fastening device comprising a needle ata distal end of a shaft.

FIGS. 23-26 show embodiments of fastening devices comprising featuresthat can assist with keeping onlay material on a needle of a fasteningdevice and reduce/eliminate the amount of stabilization force requiredduring fastener deployment.

FIGS. 27A-31 show additional embodiments of fastening devices comprisingfeatures that can reduce/eliminate the amount of stabilization forcerequired during fastener deployment.

FIGS. 32-35 show an embodiment of a fastener being deployed andinadequate placement of the second bar.

FIGS. 36-37 show an embodiment of a fastener with a flexible second barbeing deployed from a fastening device.

FIGS. 38-39 show an embodiment of a deflector that interacts with thefastener's second bar.

FIGS. 40-42O illustrate another embodiment of a fastener deflectorconfigured to interact with the fastener's filament and second bar toreorient the second bar.

FIGS. 43A-43D show an embodiment of a needle comprising a helical slot.

FIGS. 44-45 depict a withdrawal force occurring on a needle.

FIGS. 46-48 show embodiments of supports for fastening devices.

FIGS. 49A-51C show embodiments of needles comprising one or more blades.

FIG. 52 shows an embodiment of a fastener with one or more curved bars.

FIG. 53 shows an embodiment of a fastener with one or more protrusions.

FIG. 54 shows an embodiment of a fastener comprising barbs.

FIGS. 55-56B show embodiments of fasteners comprising expanding wings.

FIG. 57 shows an embodiment of a fastener comprising curling arms.

FIGS. 58A-59C show various views of two embodiments of fastenerscomprising different cross-sectional geometries.

FIG. 60 shows an embodiment of a fastener's first bar positioned withina needle.

FIGS. 61A and 61B show an embodiment of a fastener manufactured inmultiple steps.

FIGS. 62A-C show an embodiment of a fastener with bars extending indifferent directions.

FIG. 63 shows an embodiment of a fastener with a bar comprising an endfeature.

FIG. 64 shows an embodiment of a fastener with a bar comprising a bend.

FIG. 65 shows an embodiment of a fastener comprising an adjustableconnector or filament.

FIGS. 66-70 show embodiments of a fastener comprising a connector orfilament positioned at an oblique angle relative to the bars of thefastener.

FIG. 71 shows an embodiment of a fastener comprising more than onematerial.

FIGS. 72A-C show embodiments of a shaft having an articulating and/orrotating end.

FIG. 73 shows an embodiment of a shaft having a bend at its distal end.

FIGS. 74A and 74B show an embodiment of a fastening device having areplaceable cartridge.

FIGS. 75A and 75B show an embodiment of a shaft having a needle that canretract and/or advance relative to the shaft.

FIGS. 76A and 76B show an embodiment of a shaft having a sheath that canretract and/or advance relative to the needle/shaft.

FIGS. 77-79 show an embodiment of a fastening device.

FIGS. 80-83 show another embodiment of a fastening device.

FIGS. 84-89 show an embodiment of a fastening device comprising opposingjaws.

FIGS. 90-94B show another embodiment of a fastening device.

FIGS. 95A-96F show embodiments of fasteners.

FIGS. 97A-97C show embodiments of a fastener comprising a bent filamentor connector.

FIGS. 98A-B show embodiments of slotted needles.

FIGS. 99A-B show embodiments of curved slotted needles.

FIGS. 100A-B show embodiments of slotted needles.

FIGS. 101A-101G show an embodiment of a device configured to grasp andstaple materials.

FIGS. 102A-102F show an embodiment of a device configured to grasp andstaple materials.

FIGS. 103A-10H show an embodiment of a device configured to clamp andstaple materials.

FIG. 104 shows an embodiment of an upper jaw of a device configured toclamp materials.

FIGS. 105A-105G shows an embodiment of a lower jaw comprising a hook.

FIGS. 106A-106B show an embodiment of a device for grasping andpositioning materials to be stapled.

FIGS. 107A-107H show an embodiment of a method of using the device ofFIGS. 106A-106B.

FIGS. 8A-8D show an embodiment of a device for grasping and positioningmaterials to be stapled.

FIGS. 109A-109B show an embodiment of a stapling device.

FIGS. 110A-110L show an embodiment of using the device of FIGS. 9A-9B.

FIGS. 111A-111D show an embodiment of a stapling device.

FIGS. 112A-112B shows an embodiment of a staple closing mechanism.

FIGS. 113A-113J show an embodiment of a stapling device using a staplewith pre-formed features.

FIGS. 114A-114C show another embodiment of a stapling device using astaple with pre-formed features.

FIGS. 115A-F show an embodiment of using the device of FIGS. 114A-114C.

FIGS. 116A-116B shows an alternative embodiment for closing a staple.

FIG. 117 shows an embodiment of a staple with pre-formed features and apre-bent tip.

FIGS. 118A-118C show an embodiment of a staple with pre-formed featuresand a pre-bent tip.

FIGS. 119A-119C show an embodiment of a staple comprising multiplepre-bends.

FIG. 120 shows an embodiment of a jaw comprising a shroud configured tocover a staple.

FIGS. 121A-121C show an embodiment of a stapling device.

FIGS. 122A-122M show an embodiment of using the device of FIGS.121A-121C.

FIGS. 123A-123B show an embodiment of a stapling device.

FIGS. 124A-124K show an embodiment of using the device of FIGS. 123A and123B.

FIG. 125 shows an embodiment of a staple reservoir.

FIG. 126 shows an embodiment of a device 12700 comprising a stapler head12702 similar to the structure shown in FIG. 125

FIGS. 127A and 127B show an embodiment of a device comprising a staplerhead similar to the structure shown in FIGS. 123A and 123B.

FIGS. 128A-128C show an embodiment of a stapling device with anarticulating head.

FIGS. 129A-129B show an embodiment of a fang and staple stretching ahole in a target material.

FIGS. 130A-130C show an embodiment of a device with retractable fangs.

FIGS. 131A-131C show an embodiment of a fang comprising a blade.

FIG. 132 shows an embodiment of an articulating fang.

FIGS. 133A-133B show an embodiment of a fang comprising internalfeatures configured to close a staple.

FIGS. 134A-134C show embodiments of fangs with adjustable positions.

FIG. 135 shows an embodiment of a fang comprising external threads.

FIGS. 136A-136C show various embodiments of fangs.

FIG. 137 shows an embodiment of a fang configured to flip down.

FIG. 138 shows an embodiment of a fang covered by a shroud.

FIG. 139 shows an embodiment of a fang concealed in holes in a backstop.

FIGS. 140A and 140B show embodiments of staple with varying shapes.

FIGS. 141A and 141B show an embodiment of a closed staple shape.

FIGS. 142A-142D show an embodiment of a staple springing open.

FIGS. 143A-143C shows an embodiment of a staple comprising legsconfigured to stay in the closed position.

FIG. 144 shows an embodiment of a staple comprising legs configured tostay in the closed position.

FIGS. 145A-145D show an embodiment of a single user using a staplingdevices as disclosed herein.

FIGS. 146A-146D show an embodiment of a method of using a stapler toform staple legs at different times.

FIGS. 147A-147E show an embodiment of a stapling mechanism.

FIGS. 148A-148D show embodiment of fangs.

FIG. 149 shows an embodiment of a material comprising a plurality ofprepared holes.

FIGS. 150A-150D show an embodiment of a bone anchor staple.

FIGS. 151A-151C show an embodiment of a stapling device.

FIGS. 152A-152C shows an embodiment of a device configured toapproximate materials.

FIGS. 153A-153C shows an embodiment of using a polymer strand to joinmaterials.

FIGS. 154A-154E show an embodiment of a device configured to joinmaterials.

FIGS. 155A-155E show an embodiment of a device configured to joinmaterials.

FIG. 156 shows an embodiment of a device configured to grip materials.

FIGS. 157A-157D show an embodiment of a device configured to gripmaterial.

FIG. 158 shows an embodiment of a surgical robot effector end comprisinga fastening device as described herein.

FIG. 159 shows a comparison of embodiments of a robotic end effectorfastening device and a handled fastening device.

FIGS. 160-162 show an embodiment of a connection between a fasteningdevice and a surgical robot.

FIGS. 163-165 show a detailed view of an embodiment of a connectionbetween a fastening device and a surgical robot.

FIGS. 166-168 show an embodiment of a conveyance cartridge insertioninto a fastening device.

DETAILED DESCRIPTION

Disclosed herein are embodiments of a fastener device that can pierceADM or other material (e.g. synthetic mesh, resorbable mesh, tissue),facilitate ADM (or other material) positioning and tensioning, fix ADM(or other material) to soft tissue using a (polymeric, resorbable ormetal) fastener, and work with onlay procedures. The tool could also beused for any other procedure that joins soft tissues together or softtissues to materials. The devices can comprise a stapler. The device canrequire little, if any pushing force into tissue during deployment, andcan be compatible for use in multiple procedures. Such devices areunique tools that will reduce the surgeon's workload and procedure time,and prevent damage to underlying tissues and organs.

The devices disclosed herein can advantageously provide the ability toaccess confined locations. Embodiments of the device can also concealsharp features during device insertion and removal. The devices canpenetrate the toughness of the material (e.g., ADM). The devices can beused target/control the position of the material to be stapled (e.g.,ADM). The devices can be configured for use during onlay procedures. Thedevice can be configured to grasp the desired tissue or material (e.g.,ADM) and retract it away to avoid underlying structures. Some of thedevices can be configured to shield/protect underlying structures.Embodiments of the device can also be configured to recruit tissue andclose the staple. The concepts described herein can apply to a number ofprocedures (e.g., pelvic sling, dural closure) that could benefit fromthe advantages listed above. It will be appreciated that the devicesdisclosed herein can be used to manipulate material, such as ADM, butcan also be used to manipulate other materials such as other mesh,membranes, etc.

Some examples of procedures utilizing mesh (e.g., ADM) in which thedevices disclosed herein could be used include breast reconstruction,abdominal wall procedures, treatment of diabetic foot ulcers, andorthopedic procedures (e.g., reinforcing a quadriceps tendon repair,reinforcing an Achilles tendon repair, and reinforcing a rotator cuffrepair). Breast reconstruction following a mastectomy traditionallyoccurred in two stages, the tissue expansion stage and the implantstage. The introduction of ADM provided the option to convert thetwo-stage process into a single-stage (also known as direct-to-implantreconstruction). The following describes two techniques used indirect-to-implant reconstruction. In the subpectoral technique, thepectoralis muscle is released from the chest wall at the inframammaryfold. The ADM is sutured to the chest wall at the inframammary fold. Theimplant is inserted into the subpectoral pocket. The ADM is attached tothe pectoralis muscle to close the implant pocket. In the prepectoraltechnique, the implant is wrapped with ADM. The implant/ADM is placedinto mastectomy pocket on top of the pectoralis muscle. The ADM issecured to the chest wall.

In abdominal wall procedures, ADM is used to repair ventral/incisionalhernias and prophylactically reinforce the abdominal wall to preventincisional hernias. ADM can be placed in multiple locations to repairthe abdominal wall, and the devices disclosed herein could facilitatethe ADM onlay procedure.

When treating diabetic foot ulcers, after the wound is debrided, ADM issecured in place over the wound so dermal integration and healing canoccur. For reinforcing a quadriceps tendon repair, the ADM is placedover the repair and secured in place. For reinforcing an Achilles tendonrepair, the ADM is wrapped around the repaired tendon and secured inplace. As noted in the preceding examples, there are numerous proceduresin which devices and methods for piercing, manipulating, and joiningmaterials, including ADM, would be very useful.

Throughout the disclosure, the term ‘target material(s)’ is used torefer to materials that can be joined or otherwise manipulated by thedevices and using the methods described herein. The target materials caninclude mesh (e.g., ADM, synthetic mesh) tissue, membranes, etc. In someembodiments, a first target material comprises ADM to be joined to asecond target material comprising tissue. In some embodiments, a firsttarget material comprises tissue to be joined to a second targetmaterial comprising tissue. Other combinations are also possible.

Throughout the disclosure, the terms ‘fang’ and ‘needle’ can be used torefer to a sharp element that may or may not have a hollow area along atleast a portion of its interior.

Described herein are embodiments of fastening devices (e.g., staplers,etc.) that are able to fasten materials and tissue (e.g. tissue totissue, material to tissue), including synthetic mesh and tough biologicmesh such as acellular dermal matrix (ADM). As described herein, toughmaterials (such as ADM) typically require time consuming suturing asthey are unsuitable for traditional fastening devices.

The fastening devices described herein utilize one or more sharppiercing elements (e.g., needle or fang) to penetrate the material, andthen deploy a fastener (e.g., staple) therethrough. The piercing elementis sufficiently sharp to penetrate the material (e.g., synthetic mesh,ADM). The piercing element comprises a hollow interior along at least aportion of its length. The fastener or a portion of the fastener can beadvanced distally within this hollow portion. The piercing elementcomprises an open tip through which the fastener or a portion of thefastener can be pushed through a material to be joined. A push membercan be used to advance the fastener distally within and out of thepiercing element.

In some embodiments, the length of the piercing element can be selectedto minimize/avoid trauma to surrounding structures. For example, in anonlay procedure, the length of the piercing element can be selected tominimize or avoid contact with tissues and structures underlying therepair site. The length of the piercing element can also be selected tobe suitable for depositing one end of the fastener at a depth in tissue.

For example, the length of the piercing element can be about 0.240 in(or about 0.100 in-0.380″, or about 0.140 in-0.340 in, or about 0.190in-0.290 in, or about, 0.220 in-0.260 in, or about 0.230 in-0.250″, orabout 0.235 in-0.245 in, etc.).

There are known devices that deliver a fastener through a hollow needle.Examples of such devices are taught in U.S. Pat. No. 4,006,747. Suchdevices however are taught as having long needles used to pass throughthe tissues to be joined, such that the needle exits the tissue on theopposite side of a wound to be closed. These needles would be unsuitablefor preventing trauma to underlying structures (e.g., in an onlayprocedure). Additionally, such devices are generally configured to usewith more than one operator. The fastening devices described herein canbe used by a single person to perform repairs.

The fastening devices can comprise a design including, but not limitedto those shown in any or a combination of FIGS. 2-9, 11-19, 22-51C,72A-84B, 98A-101G, 103A-107H, 121A-148D.

A method for using such fastening devices comprises inserting one ormore piercing elements of a fastening device into or through a material(e.g., synthetic mesh, ADM, or tissue). The method further comprisesadvancing a fastener (e.g., stapler, other fastener, etc.) along aninterior of the piercing element. The method comprises pushing thefastener or a portion of the fastener through the material and out ofthe distal tip of the piercing element.

The method can comprise creating one or more openings or passagesthrough material by inserting the piercing element(s) into or throughthe material. The method can comprise passing a fastener or a portion ofa fastener through the openings or passages created by the piercingelement.

As noted above, the devices that are disclosed herein can beparticularly advantageous in onlay procedures such as abdominal wallrepairs. The devices and methods disclosed herein provide manyadvantages over what is currently available. Currently, other optionsfor securing onlay mesh in open abdominal wall repairs include suture,metal staples or tacks, and fibrin glue. If a surgeon uses ADM, theywould likely have to use suture (with a needle) in order to penetratethe toughness of ADM. However, suturing greatly increases the proceduretime and is relatively difficult and technique dependent, which couldaffect clinical outcomes. Stapling and tacking are unsuitable forpenetrating the toughness of ADM, and fibrin glue is costly. The devicesdisclosed herein can advantageously penetrate the toughness of ADM orother mesh, and can deploy repeatable fasteners quickly, providingsolutions to these problems.

In intraperitoneal onlay mesh repairs (IPOM repairs), devices includingbarbed tacks and spiral metal tacks can be used. In such repairs, themesh is generally introduced into the abdominal cavity and covers thehernia defect on the abdominal cavity side of the peritoneum. The tacksare deployed outwards and embed in the abdominal muscle, which generallyresults in pain for the patient. When using resorbable tacks, the painis supposed to subside as the tacks resorb. When using metal tacks, thepatient may have to return for a second surgery to remove the tacks toalleviate pain. The devices disclosed herein could advantageously securethe material being joined (e.g. mesh) by anchoring one end of thefastener against the fascia. This would eliminate the need to embed aportion of the fastener in muscle, increasing patient comfort.

FIG. 2 shows an embodiment of a fastener device 100 that includes theneedle 102, shaft/fastener reservoir 104, handle 106, deployment trigger108, and fastener 118 (FIG. 8 ). The needle 102 can be sharp enough topenetrate a tough material like ADM and be configured to allow passageof a fastener therethrough.

FIG. 3 shows the onlay material (e.g., ADM) 110 and tissue 112 to bejoined. FIGS. 4-9 show the basic procedure for fixing the material 110(e.g., ADM) to tissue 112 using the fastener device 100. In FIG. 4 , theuser applies a distal force via the handle to pierce the material 110and tissue 112 with the needle 102.

In FIGS. 5-7 , the user has the option to withdraw the needle out of thetissue from the first location 114 (FIG. 5 ), position or tension thematerial (e.g., ADM) as needed (FIG. 6 ), and then pierce the tissue ata second location 116 (FIG. 7 ).

Because there is friction/compression between the material (e.g., ADM)and needle, the material can stay on the needle when the userwithdrawals the needle out of the tissue. Described in more detail below(e.g., with respect to FIGS. 23-26 ) are a number of features thatfacilitate repositioning.

In FIG. 8 , the user applies a stabilizing force against the material(e.g., ADM) and tissue, and simultaneously actuates the deploymenttrigger 108. This deploys the fastener 118 and fixes the material 110 totissue 112. Described in more detail below (e.g., with respect to FIGS.23-31 ) are a number of ways to reduce/eliminate the requiredstabilizing force.

In FIG. 9 , the user applies a proximal force via the handle to withdrawthe needle out of the material (e.g., ADM) and tissue. Described in moredetail below (e.g., with respect to FIGS. 44-51 ) are a number offeatures that aid needle withdrawal.

FIG. 10 shows an embodiment of a fastener implant 200 that is made of apolymeric or resorbable material, or metal. For example, the implant cancomprise nylon, polyethylene, polypropylene, various resorbable polymersor Nitinol. The fastener has a first bar 202 and second bar 204 oneither end of a connector 206 (e.g., filament). In FIG. 11 , the firstbar resides in the lumen 208 of the slotted delivery needle 210. Thefastener can comprise a rectangular cross section, as shown in FIG. 10 .The rectangular cross section of the first bar contains flat faces toimprove the resistance of the fastener pulling out of tissue. Othershape cross section are also possible (e.g., circular, ovular, etc.). Insome embodiments, different portions of the fastener can comprise thesame or different cross sections. In some embodiments, differentportions of the fastener can comprise the same or different dimensions.The fastener's filament 206 exits the delivery needle slot 212, and thesecond bar 204 resides on the outside of the needle. The filament lengthis sized to approximate and/or compress the tissue and mesh to bejoined. For example, in an open onlay repair, the filament length can beselected so that the bar embeds in muscle. Examples of suitabledimensions are described with respect to FIGS. 95A-96C. In alaparoscopic IPOM repair, the filament length can be selected so thatthe bar gets deployed on the opposite side of the peritoneum/fascia, anddoes not embed in muscle, to avoid pain to the patient.

FIG. 12 shows a shoulder 214 that controls and limits the insertiondepth of the needle. The shoulder could have a fixed or adjustabledistance from the needle tip 216. The shoulder can control thedeployment depth of the fastener's first bar and control the amount ofapproximation and/or compression between the onlay material and thetissue. In embodiments comprising a fixed distance shoulder, thedistance can be about 0.235″ (or about 0.17-0.30″ or about 0.185-0.285″or about 0.20-0.27″, etc.).

In FIG. 13 , the needle 216 pierces the onlay material 218 (e.g., ADM orother mesh) and tissue 220 until the shoulder 214 contacts the material218 (e.g., ADM). The user has the option to advantageously withdraw theneedle out of the tissue 220 before deploying the fastener (with thematerial remaining on the needle) to position or tension the onlaymaterial 218 as needed.

In FIG. 14 , as the push rod (not shown, inside the needle lumen)advances the first bar down the needle's lumen, the deflector 222 actson the fastener's filament. This action reorients the second bar 204 andprepares it to seat on the surface of the onlay material (e.g., ADM).Described in more detail below (e.g., FIGS. 32-43D) are a number ofother embodiments to optimize the placement of the second bar 204 andthe onlay material/tissue approximation and/or compression.

In FIG. 15 , the first bar and filament get delivered through the onlaymaterial 218 (e.g., ADM) and embedded into tissue 220 by travelingthrough the hole in the material 218 that the slotted needle created.Concurrently, the second bar 204 seats on the surface of the onlaymaterial 218 (e.g., ADM). During this step the user applies astabilizing force against the onlay material 218 and tissue 220 toensure that the material does not get pushed off of the needle.

In FIGS. 16 and 17 , the push rod 224 deploys the first bar 202 intotissue 220 (represented as clear to allow visualization).

In FIGS. 18 and 19 , the push rod is retracted, and the needle iswithdrawn from the tissue 220 and onlay material 218 (e.g., ADM),leaving the onlay material and tissue approximated and/or compressed andfixed together by the fastener.

In some embodiments, as shown in FIG. 20 , the fastener's bar comprisesblunt ends 226. The blunt ends can advantageously prevent the bar fromunintentionally penetrating any fascia that may lie below the targetmuscle tissue. Because the needle handles the piercing through the onlaymaterial (e.g., ADM), it is not necessary for the fastener to comprisesharpened ends. The blunt ends can comprise square or rectangular endsas shown in FIG. 20 . The blunt ends can be rounded, in someembodiments.

FIG. 21 shows an embodiment of a fastener where the second bar has adifferent (in this example, shorter) length L and different (in thisexample, taller) height H than the first bar. The shorter length allowsthe fastener to be positioned close to the edges of the onlay material(e.g., ADM) without the ends of the bar protruding significantly pastthe edge(s) of the material. The taller height increases the stiffnessand strength of the bar. In another embodiment, a shorter height reducesthe bar's profile on the onlay material (e.g., ADM), which could benefitthe repair. In some embodiments, a larger width of the second bar can beused to increase contact surface area of the bar.

FIG. 22 shows an embodiment of a needle 228 on the end of a shaft 230.The shaft (e.g. diameter and length) is sized to enable access to doopen or laparoscopic procedures.

Embodiments of Features that Facilitate Repositioning

FIG. 23 shows an embodiment of a needle comprising one or more barbs 300that assist with keeping the onlay material 302 (e.g., ADM) on theneedle to (re)position and/or tension the material 302. The needlepierces the onlay material 302, and the barbs 300 keep the onlaymaterial 302 on the needle. The user pulls the needle out of the tissuefrom a first location, but the barbs keep the onlay material on theneedle. The user repositions the needle to (re)position or tension theonlay material, then inserts the needle in tissue at a second location.To enable needle withdrawal from the ADM, a support (e.g. FIGS. 46-48 )could be used to withdraw the barbed needle out of the ADM.Alternatively, the barbs could retract to facilitate needle withdrawal.

FIG. 24 shows an embodiment comprising one or more raised bumps 304 thatassist with keeping the onlay material (e.g., ADM) on the needle to(re)position and/or tension the onlay material.

FIG. 25 shows an embodiment comprising one or more notches 306 thatassist with keeping the onlay material (e.g., ADM) on the needle to(re)position and/or tension the onlay material.

FIG. 26 shows an embodiment comprising an enlargement 308 on the needle.The enlargement increases the compressive force 310 of the onlaymaterial (e.g., ADM) on the needle. The increased compressive forceassists with keeping the onlay material on the needle to (re)positionand/or tension the onlay material.

Embodiments of Features to Reduce or Eliminate the Amount ofStabilization Force Required During Fastener Deployment

When the first bar and filament pass through the hole in the onlaymaterial (e.g., ADM) created by the needle, the amount of interferencethe first bar and filament encounter with the onlay material depends onthe size of the passageway through the onlay material created by theneedle. The amount of interference affects the force required to pushthe first bar and filament through the needle's passageway in the onlaymaterial. The force the first bar and filament apply to the onlaymaterial must have a counteracting “stabilization” force on the onlaymaterial so the first bar and filament can pass through the passagewaywithout pushing the onlay material off the needle. One way to keep theonlay material on the needle is for the user to apply a distal force tothe device/needle during fastener deployment. Current design featuresbalance competing needs between 1) reducing the amount of force requiredfor the needle to pierce the ADM, and 2) reducing the requiredstabilizing force. To reduce the required stabilizing force, theneedle's inner and outer diameters are sized to create a sufficientlysized passageway in the ADM so the fastener's first bar and (folded)filament are able to pass through the ADM with minimal force. Byminimizing the force to pass the fastener through the ADM, thestabilizing force required by the user is also reduced. Using a largersize needle would create a larger passageway in the ADM that wouldfurther reduce the force to pass the fastener through the ADM (andfurther reduce the stabilizing force required by the user). However, alarger size needle would also increase the amount of force required forthe needle to pierce the ADM. Consequently, the needle design achieves abalance between the two competing needs by using a tri-bevel tip designwith a primary bevel angle that minimizes the amount of force requiredfor the needle to pierce ADM. The tri-bevel tip design also maintainsdurability for the needle tip's repeated use. Examples of primary bevelangles include 20-24 degrees, and 14-30 degrees. The following conceptsdescribe embodiments of features than can help to further minimize theamount of stabilization force required by the user during fastenerdeployment.

The features shown in FIGS. 23-26 could also be used to assist withkeeping the onlay material (e.g., ADM) on the needle during fastenerdeployment. This assistance could reduce or eliminate the amount ofstabilization force the user needs to apply during fastener deployment.To enable needle withdrawal, a support (e.g. FIGS. 46-48 ) could be usedto withdraw the needle out of the onlay material. Alternatively, withreference to FIG. 23 , the barbs could retract to facilitate needlewithdrawal.

FIG. 27A shows an embodiment comprising one or more blades 400 on theneedle. The blades cut slits 402 through the onlay material (e.g., ADM)404 so that when the onlay material flap 406 in needle lumen folds whenthe first bar and filament pass through the onlay material, the tallerflap creates more space through the onlay material. As a result, thefirst bar and filament can pass through the onlay material with lessforce so that the user can also apply less force on the onlay materialduring fastener deployment. FIG. 27B shows a comparison to a smallerflap size (without slits).

As shown in the embodiment of FIG. 28 , after the fastener deliveryneedle 408 pierces through onlay material 410 (e.g., ADM) and intotissue 412, one or more barbs 414 can deploy from the fastener deliveryneedle into tissue. The user could then lift/keep the onlay material andtissue away from any underlying structures and deploy the fastenerwithout unintentionally fastening underlying structures. Unintentionallyfastening underlying structures can sometimes be caused by having topush into the onlay material/tissue during deployment.

As shown in the embodiments of FIGS. 29-31 , after the fastener deliveryneedle 416 pierces through onlay material 410 (e.g., ADM) and intotissue 412 (FIG. 29 ), one or more barb deployment needles 418 piercethrough onlay material and into tissue (FIG. 30 ). Then, barbs 420deploy from the barb deployment needles into tissue. The user could thenlift/keep the onlay material and tissue away from any underlyingstructures and deploy the fastener without unintentionally fasteningunderlying structures. Unintentionally fastening underlying structurescan sometimes be caused by having to push into the onlay material/tissueduring deployment.

Embodiments of Features to Optimize the Placement of the Second Bar

Without one or more deflectors (e.g., deflector 222 of FIG. 14 ), thesecond bar's deployment can get arrested resulting in suboptimalapproximation and/or compression between the onlay material (e.g., ADM)and tissue. FIG. 32 shows the second bar 506 outside the needle slot 504as it moves towards the onlay material. As shown in FIGS. 33 and 34 ,the distal end of the bar 500 seats itself on the onlay material, andthe proximal end of the bar 502 can enter the needle slot 504. Thisconfiguration prevents the second bar 506 from seating on the onlaymaterial during deployment. As shown in FIG. 35 , the resulting gap 508between the second bar 506 and onlay material prevents the second bar506 from approximating and/or compressing the onlay material to tissue.The deflector 222 solves this problem by deflecting the fastener'sfilament to reorient the second bar 506 so that it seats on the onlaymaterial to approximate and/or compress the onlay material to tissue.The following concepts describe alternate ways to optimize the placementof the second bar and the onlay material/tissue approximation and/orcompression.

FIG. 36 shows an embodiment of a fastener with a second bar that has ashorter height. The shorter height makes the second bar more flexible sothat when the second bar encounters the configuration illustrated inFIG. 34 , the bar flexes. The flexed second bar 510 enables the junction512 between the filament and second bar to advance to the onlaymaterial. By allowing the junction between the filament and second barto advance to the onlay material, the gap between the second bar andonlay material is eliminated, and the fastener can approximate and/orcompress the onlay material to tissue, as shown in FIG. 37 .

FIGS. 38 and 39 show an embodiment of a deflector 514 that interactsdirectly with the fastener's second bar 516. The deflector curves in oneor more directions, shown by a first direction 518 (e.g., upward, shownin the side view of FIG. 38 ) and a second direction 520 (e.g., inward,shown in the top view of FIG. 39 ). Both curvatures or directions acttogether to deflect the second bar. The deflector 514 reorients thesecond bar 516 to seat on the onlay material (e.g., ADM).

FIGS. 40-42O illustrate another embodiment of a fastener deflectorconfigured to interact with the fastener's filament and second bar toreorient the second bar so that it seats on the onlay material (e.g.,ADM). FIGS. 40 and 41 show the side and top views, respectively, of thedistal end of a fastening device 4100. FIGS. 40 and 41 show slottedneedle 4102 extending from the distal end of shaft 4104. Moving distallyalong the shaft 4104, a first or bottom ramp 4106 extends upwards oraway from a bottom side 4108 of the shaft. Positioned distal to thestart of the first ramp 4106 is a second or side ramp 4110 whichprojects from a side wall 4112.

FIGS. 42A-O show an embodiment of a fastener 4200 being deployed from afastening device 4100 like that shown in FIGS. 40 and 41 . FIGS. 42A-Cshow top, side, and front views, respectively, of the fastener'sfilament 4202 extending from the slotted needle 4102.

FIGS. 42D-F show top, side, and front views, respectively, of thefastener 4200 being pushed distally along the slotted needle 4102,causing the bottom ramp 4106 to lift the fastener's filament 4202,elevating the fastener's second bar 4204 above the needle 4102.

FIGS. 42G-I show top, side, and front views, respectively, of thefastener 4200 continuing to be pushed distally along the needle 4102,causing the bottom ramp 4106 to continue to lift the filament 4202 andsecond bar 4204, and causing the side ramp 4110 to rotate the second bar4204 so that an end 4206 of second bar rotates towards the needle 4102.

FIGS. 42J-L show top, side, and front views, respectively, of thefastener 4200 continuing to be pushed distally along the needle 4102,causing the bottom ramp 4106 continuing to lift the second bar 4204 andthe side ramp 4110 continuing to rotate the second bar 4204 above theneedle 4102. As shown in this set of figures, the second bar 4204 is nowlargely parallel to the surface of the onlay material.

FIGS. 42M-O show top, side, and front views, respectively, of the sidewall 4208, best shown in FIG. 42N maintaining the position of the secondbar 4204 during deployment of the fastener.

FIGS. 43A-43D show an embodiment of a needle comprising a helical slot530 in the needle. The helical slot reorients the second bar 532 to seaton the onlay material (e.g., ADM) as the fastener is being deployed fromthe needle. When the end 534 of the second bar 532 makes contact withthe onlay material (e.g., ADM), the rotational movement of the fastener536 causes the second bar 532 to pivot about the end 534 so that itseats on the onlay material.

Reorienting the second bar so that it moves towards a position parallelto a surface of the onlay material provides the advantage of improvedapproximation and/or compression of the onlay material and tissue, asdescribed above. It also provides the advantage of allowing the surgeonto hold the fastening device at an angle other than perpendicularrelative to the onlay material and tissue. The surgeon can approach thetreatment site from any angle while still being assured of reliable andconsistent positioning of the fastener.

Embodiments of Features that Aid Needle Withdrawal

After the needle 600 pierces the onlay material 602 (e.g., ADM), thereis a compressive force 604 between the onlay material and the needlethat acts to keep the onlay material on the needle. Consequently, a“withdrawal” force 606 is required to pull the needle out of the onlaymaterial (FIG. 44 ). This withdrawal force also causes the onlaymaterial 602 to apply a “pull out” force 608 that acts to pull thefastener 610 out of tissue 612 and/or compromise the fastener'sretention in tissue (FIG. 45 ). The following concepts describe ways toaid needle withdrawal to preserve the fastener's retention in tissue.The following concepts would also aid needle withdrawal when used withany features that assist with keeping the onlay material on the needleto (re)position and/or tension the onlay material (e.g., like thosedescribed with respect to FIGS. 23-26 ).

FIG. 46 shows an embodiment of a support 614 that actuates and contactsthe fastener 616 to provide countertraction while the needle 618withdraws from the onlay material 620 (e.g., ADM). The support cancomprise one or more elongated features or a shaft that extends past theneedle and can provide a force on the onlay material while the needle isbeing withdrawn. FIG. 47 shows an alternative embodiment of a support622 that contacts the onlay material to provide countertraction. Thesupport 622 has a distal feature that extends radially outward so thatthe support 622 does not contact the fastener 616, and only contacts theonlay material around the fastener. FIG. 48 shows another embodiment ofa support 624 that contacts both the fastener and the onlay material toprovide countertraction. In FIGS. 46-48 , the shoulder 214 (above) couldalso serve as the support. Alternatively, the support could be aseparate element. In some embodiments, the support is dual purposed toalso serve as a needle protector/cover.

FIG. 49A shows a front view of an embodiment of a needle 626 throughonlay material 628 (e.g., ADM). FIG. 49B shows a bottom view of theonlay material hole compressing the outside diameter (OD) of the needle.One or more blades 630 are positioned around the perimeter of the needle626. In the front view of FIG. 50A and bottom view of FIG. 50B, theblades 630 are actuated (e.g., advanced distally) to cut slits throughthe perimeter of the hole, thereby relieving the onlay material'scompression on the OD of the needle. With the compression relieved, theneedle can be easily withdrawn from the onlay material.

FIGS. 51A-51C show an alternative embodiment where one or more blades630 are fixed around the perimeter of the needle 626. When the needlepierces the onlay material 628 (e.g., ADM), the blades simultaneouslycut slits through the perimeter of the hole, thereby relieving the onlaymaterial's compression on the OD of the needle. With the compressionrelieved, the needle can be easily withdrawn from the onlay material.

Other Fastener Embodiments

FIG. 52 shows an embodiment of a fastener with a curved first bar 700 toimprove the fastener's retention in tissue, and a curved second bar 702to improve the fastener's retention to the onlay material (e.g., ADM).The curved bars would also assist approximating and/or compressing theonlay material to tissue. The curved second bar 702 could also preventthe bar's ends from pointing upward (e.g. away from the onlay materiallike a “V”) and from moving (e.g. spinning) on the onlay material.

FIG. 53 shows an embodiment of a fastener that has one or more downwardpointing (e.g., pointing towards the first bar) protrusions 704 on thesecond bar 706 that prevent the second bar from moving (e.g. spinning)on the onlay material (e.g., ADM).

FIG. 54 shows an embodiment of a fastener with multiple barbs 708 onboth/either the fastener's filament 710 and/or the fastener's first bar712. The barbs are oriented to allow the filament and first bar to beeasily deployed through the onlay material (e.g., ADM) and into tissue,but make it difficult to pull the fastener out of tissue and the onlaymaterial.

FIG. 55 shows an embodiment of a fastener with a first bar 714 that hasone or more expanding wings 716. The wings are oriented to allow thefirst bar to be easily deployed into tissue, but make it difficult topull the fastener out of tissue. The wings are oriented in a same planeas the fastener.

FIGS. 56A and 56B show an embodiment of a fastener with a first bar 718that has one or more expanding wings 720. The wings are oriented toallow the first bar to be easily deployed into tissue, but make itdifficult to pull the fastener out of tissue. The wings are alsooriented to expand out of the fastener's plane, as shown in FIG. 56B, sothat if the first bar 718 is deployed in the same direction as themuscle fibers 722, the wings expand across the muscle fibers to improvethe fastener's retention strength in tissue.

FIG. 57 shows an embodiment of a fastener with a first bar 724 with armsthat curl 726 when deployed from the needle. The arms curl out of thefastener's plane across the muscle fibers 728 so that if the first baris deployed in the same direction as the muscle fibers, the curled armsimprove the fastener's retention strength in tissue.

FIGS. 58A-C and 59A-C show a front view, a side view, and a blown upside view, respectively, of two fasteners. FIGS. 58A-C show a fastener730 that has a first bar 732 with a circular cross-section. The circularcross-section has a diameter 734 that is less than the diameter 736 of acircumscribed circle around a first bar 738 of a fastener 740 that has arectangular/square cross-section of comparable stiffness/strength, shownin FIGS. 59A-C. The smaller diameter 734 allows the first bar 732 to fitinside a needle that has a smaller inner diameter (ID). In other words,a fastener with a rectangular/square cross section would need a largerdiameter slotted needle than a fastener with a circular cross section ofcomparable stiffness/strength. The potential benefits of a needle with acorresponding smaller outer diameter (OD) include lower force to piercethe onlay material (e.g., ADM) with the needle and lower force towithdraw the needle from the onlay material. Another potential benefitof the smaller diameter 734 first bar 732 is additional space in aneedle that is sized for the rectangular/square cross section. Theadditional space could reduce the amount of stabilization force requiredby the user during fastener deployment (e.g., as described above withrespect to FIGS. 23-31 ).

As shown in FIGS. 58A-C, in some embodiments, the fastener 730 couldalso have a connector or filament 742 with a height 744 that is smallerthan the diameter 734 of the first bar 732. As shown in FIG. 60 , thisallows the needle slot 746 to prevent the first bar 732 fromunintentionally coming out of the needle's lumen 748. The second bar 750could have a different or the same diameter as the first bar 732.

As shown in FIGS. 61A and B, in some embodiments, the fastener 752 couldbe fabricated in multiple steps, with the initial step producing apreliminary shorter filament length 754 (FIG. 61A). In a subsequentmanufacturing step, the filament could be stretched to a longer length756 (FIG. 61B). The stretching could serve multiple purposes. First, forpolymers susceptible to stretch under certain loads, the stretchingmanufacturing process could reduce/eliminate stretch that could occurafter implantation. As a result, the approximation and/or compressionbetween the onlay material (e.g., ADM) and tissue achieved at the timeof implantation could be better maintained over time to benefit healing.Second, the stretching will reduce the filament's cross-sectionalgeometry. This could create more space in the needle's lumen for thefirst bar 758 and filament 756 to pass through the onlay material. Theadditional space could reduce the amount of stabilization force requiredby the user during fastener deployment (e.g., as described above withrespect to FIGS. 23-31 ). The filament's smaller cross-sectionalgeometry would also enable a smaller needle slot width that can preventthe first bar from unintentionally coming out of the needle's lumen (asillustrated in FIG. 60 ). Third, the stretching will make the filamentmore flexible. The additional filament flexibility could facilitatereorientation of the second bar 760 to optimize placement of the secondbar and the onlay material/tissue approximation and/or compression(e.g., as described above with respect to FIGS. 32-43D).

Alternatively, the stretching could also be done in the device at thetime of deployment to a variable or predetermined length.

FIGS. 62A-C shows an embodiment of a fastener with a first bar 762 and asecond bar 764 extending in different directions. The directions couldbe different than what is illustrated in FIG. 62 . Having the second barextend in a different direction than the first bar could optimizeplacement of the second bar and the onlay material (e.g., ADM)/tissueapproximation and/or compression (e.g., as described above with respectto FIGS. 32-43D). The fasteners could convey down the shaft/fastenerreservoir 104 in an unstressed configuration as shown in FIG. 62 anddeploy. Alternatively, the fasteners could convey down theshaft/fastener reservoir 104 with the bars deformed/stressed into thesame plane (e.g. like an “H” as shown in FIG. 10 ) and then recover tothe unstressed (out-of-plane) configuration (e.g. as shown in FIG. 62 )for deployment.

FIG. 63 shows an embodiment of a fastener with a second bar 766 that hasan end feature 768 (such as a chamfer). When the end feature contactsthe onlay material (e.g., ADM) during deployment, the end feature causesthe proximal end 770 of the second bar to tilt and avoid the needleslot. This could optimize placement of the second bar and the onlaymaterial (e.g., ADM)/tissue approximation and/or compression (e.g., asdescribed above with respect to FIGS. 32-43D).

FIG. 64 shows an embodiment of a fastener with a second bar 772 that hasa bend 774. When the bent end travels towards the needle slot duringdeployment, the bend causes the second bar to glance off the needle andavoid the needle slot. This could optimize placement of the second barand the onlay material (e.g., ADM)/tissue approximation and/orcompression (e.g., as described above with respect to FIGS. 32-43D).

To provide additional control over the onlay material (e.g., ADM)/tissueapproximation and/or compression, the fastener could incorporate anadjustable length filament.

One such embodiment is shown in FIG. 65 , with adjustable lengthfilament 776. After adjusting the filament to the proper length (eitherbefore or after implantation), the excess filament 778 could be trimmedif desired.

FIGS. 66 and 67 show an embodiment of a fastener that has a filament 780at an oblique angle to the fastener's first bar 782 and second bar 784in order to facilitate a smaller crossing profile 786 for theshaft/fastener reservoir 104. FIG. 67 shows the smaller crossing profile786 compared to the larger crossing profile 788 (FIG. 68 ) of theshaft/fastener reservoir containing fasteners that have a filamentperpendicular to the fastener's bars (FIG. 69 ).

The fasteners could convey down the shaft/fastener reservoir 104 in anunstressed configuration as shown in FIGS. 66 and 67 and deploy.Alternatively (as shown in FIG. 70 ), the fasteners could bedeformed/stressed from the configuration shown in FIG. 69 to theconfiguration shown in FIG. 66 while they convey down the shaft/fastenerreservoir 104. The fasteners could recover to the unstressedconfiguration (shown in FIG. 69 ) for deployment.

FIG. 71 shows an embodiment of a fastener that could comprise or be madefrom more than one material that would 1) have more favorablestrain-related properties in the filament direction 790 that mayfacilitate an elastic benefit holding/approximating and/or compressingthe onlay material (e.g., ADM)/tissue, and/or 2) have differentproperties on both/either the first bar 792 and/or second bar 794 toprevent mobility.

FIGS. 95A-95C show front perspective, front and side views,respectively, of an embodiment of a fastener 9500 having a singlethickness. The thickness 9520 (FIG. 95C) of the fastener can be about0.03 in (or about 0.01 in-0.05 in, about 0.02 in-0.04 in, about 0.025in-0.035 in, etc.). In some embodiments, the dimensions of the first barand second bar are selected such that the first bar has a flexibility orstiffness to curl (or disengage from the needle) upon being deployedfrom the fastening device, and the filament or connector connecting thefirst bar and the second bar is strong enough to withstand the forcesexerted on it when the first bar is deployed from the needle. In someembodiments, a length 9508 of the first bar is about 0.33 in (or about0.23 in-0.43 in, or about 0.325 in-0.335 in, etc.). In some embodiments,a height 9510 of the first bar is about 0.03 in (or about 0.01 in-0.05in, about 0.02 in-0.04 in, about 0.025 in-0.035 in, etc.). In someembodiments, a width 9512 of the filament or connector is about 0.02 in(or about 0.01 in-0.03 in or about 0.015 in-0.025 in, etc.). In someembodiments, a length 9514 of the filament or connector 9506 is about0.17 in (or about 0.10 in-0.24 in, 0.15 in-0.19 in, 0.16 in-0.18 in,0.165 in-0.175 in, etc.). In some embodiments, a length 9516 of thesecond bar is about 0.23 in (or about 0.13 in-0.33 in or about 0.225in-0.235 in, etc.). In some embodiments, a height 9518 of the second baris about 0.04 in (or about 0.01 in-0.07 in, 0.02 in-0.06 in, 0.03in-0.05 in, 0.035 in-0.045 in, etc.).

FIGS. 96A-C show another embodiment of a fastener 9600 comprising uniquesizes for the first bar 9602, the second bar 9604, and the filament9606. For example, the first bar 9602 and the second bar 9604 havecircular cross sections. As described above, the dimensions of the firstbar and second bar are selected such that the first bar has aflexibility or stiffness to curl (or disengage from the needle) uponbeing deployed from the fastening device, and the filament or connectorconnecting the first bar and the second bar is strong enough towithstand the forces exerted on it when the first bar is deployed fromthe needle. In some embodiments, a diameter 9608 of the first bar 9602is about 0.035 in (or about 0.02 in-0.05 in, 0.025 in-0.045 in, or about0.03 in-0.04 in, etc.). In some embodiments, a diameter 9610 of thesecond bar 9604 is about 0.04 in (or about 0.01 in-0.07 in, 0.02 in-0.06in, 0.03 in-0.05 in, 0.035 in-0.045 in, etc.). In some embodiments, athickness 9612 of the filament or connector 9606 is about 0.026 in (orabout 0.016 in-0.036 in or about 0.021 in-0.031 in, etc.). In someembodiments, a length 9614 of the first bar 9602 is about 0.33 in (orabout 0.23 in-0.43 in, or about 0.325 in-0.335 in, etc.). In someembodiments, a length 9616 of the filament or connector 9606 is about0.17 in (or about 0.10 in-0.24 in, 0.15 in-0.19 in, 0.16 in-0.18 in,0.165 in-0.175 in, etc.). In some embodiments, a width 9618 of thefilament or connector 9606 is about 0.020 in (or about 0.01 in-0.03 inor about 0.015 in-0.025 in, etc.). In some embodiments, a length 9620 ofthe second bar 9604 is about 0.23 in (or about 0.13 in-0.33 in or about0.225 in-0.235 in, etc.).

FIGS. 96D-F show another embodiment of a fastener 9630 comprising uniquesizes for the first bar 9632, the second bar 9634, and filament 9636.For example, the first bar 9632, the second bar 9634, and filament 9636have rectangular cross sections. As described above, the dimensions ofthe first bar and second bar are selected such that the first bar has aflexibility or stiffness to curl (or disengage from the needle) uponbeing deployed from the fastening device, and the filament or connectorconnecting the first bar and the second bar is strong enough towithstand the forces exerted on it when the first bar is deployed fromthe needle. In some embodiments, the thickness 9638 of the first bar(FIG. 96F) can be about 0.039 in (or about 0.019 in-0.059 in, about0.029 in-0.049 in, about 0.034 in-0.044 in, etc.), the height 9640 ofthe first bar (FIG. 96E) can be about 0.033 in (or about 0.013 in-0.053in, about 0.023 in-0.043 in, about 0.028 in-0.038 in, etc.), and thelength 9642 of the first bar (FIG. 96E) can be about 0.33 in (or about0.23 in-0.43 in, or about 0.325 in-0.335 in, etc.). In some embodiments,the thickness 9644 (FIG. 96F) of the filament or connector 9636 can beabout 0.030 in (or about 0.010 in-0.050 in, about 0.020 in-0.040 in,about 0.025 in-0.035 in), the width 9646 (FIG. 96E) of the filament orconnector 9636 can be about 0.021 in (or about 0.011 in-0.031 in orabout 0.016 in-0.026 in, etc.), and the length 9648 (FIG. 96E) of thefilament or connector 9636 can be about 0.188 in (or about 0.118in-0.258 in, about 0.138 in-0.238 in, about 0.168 in-0.208 in, about0.178 in-0.198 in, about 0.183 in-0.193 in). In some embodiments, thethickness 9650 of the second bar (FIG. 96F) can be about 0.039 in (orabout 0.019 in-0.059 in, about 0.029 in-0.049 in, about 0.034 in-0.044in, etc.), the height 9652 of the second bar (FIG. 96E) can be about0.026 in (or about 0.016 in-0.036 in, about 0.021 in-0.031 in), and thelength 9654 of the second bar (FIG. 96E) can be about 0.23 in (or about0.13 in-0.33 in or about 0.225 in-0.235 in, etc.).

FIGS. 97A-D show another embodiment of a fastener 9700 that has a bentfilament or connector 9702. The bent filament or connector canfacilitate a smaller crossing profile 9704 for the shaft/fastenerreservoir 104. FIG. 97C shows the smaller crossing profile 9704 comparedto the larger crossing profile 9706 (FIG. 97D) of a fastener that has astraight filament or connector 9708. The bent filament could also serveto optimize placement of the second bar 9710 and onlay material (e.g.,ADM)/tissue approximation and/or compression (e.g., as described abovewith respect to FIGS. 32-43D).

Other Delivery Device Embodiments

As shown in FIGS. 72A-C, in some embodiments, the shaft 800 could havean articulating end 802 (FIGS. 72A&B) and/or a rotating end 804 (FIG.72C) to facilitate access in open and/or laparoscopic procedures.

As shown in FIG. 73 , the shaft can have a fixed bend 806 at the distalend to facilitate access in open procedures.

As shown in FIGS. 74A and 74B, in some embodiments, the delivery devicecould have a replaceable cartridge (e.g. when the fasteners aredepleted). The replaceable cartridge could involve the entire shaft 808(FIG. 74A) or just the distal portion 810 of the shaft (FIG. 74B). Ifthe needle were part of the replaceable cartridge, the user would alsobenefit from the new needle on the cartridge.

As shown in FIGS. 75A and 75B, in some embodiments, the needle 812 couldadvance out of the shaft 814 (FIG. 75B) and retract back into the shaft(FIG. 75A). With the needle in the retracted position, the sharp needlepoint is protected and prevents atraumatic injury while the user insertsthe device to the repair site (e.g. via laparoscopic or open approach).Once the device is at the repair site, the user advances the needle outof the shaft.

As shown in FIGS. 76A and 76B, in some embodiments, a sheath 816 couldadvance over the needle 818 (FIG. 76A) and retract to expose the needle(FIG. 76B). With the sheath in the advanced position, the sharp needlepoint is protected and prevents atraumatic injury while the user insertsthe device to the repair site (e.g. via laparoscopic or open approach).Once the device is at the repair site, the user retracts the sheath toexpose the needle. After deploying the fastener, the sheath could beadvanced to also apply countertraction to the onlay material (e.g., ADM)while the user withdraws the needle out of the onlay material (e.g.,similar to the embodiments that aid needle withdrawal described withrespect to FIGS. 44-51 ).

FIGS. 98A-B show another embodiment of a slotted needle 9800 comprisinga unique outer diameter (OD) 9802, inner diameter (ID) 9804, and slotwidth 9806. As described above, the ID dimension is selected such thatthe bar of the fastener can reside in the ID, and the slot widthdimension is selected such that the bar connector (a.k.a. filament) cantravel down the length of the slot (with either an interference orclearance fit with the slot). In some embodiments, an OD 9802 is about0.078 in (or about 0.018 in-0.148 in, 0.048 in-0.108 in, 0.068 in-0.088in, etc.). In some embodiments, an ID 9804 is about 0.063 in (or about0.010 in-0.140 in, 0.040 in-0.100 in, 0.060 in-0.080 in, etc.). In someembodiments a slot width 9806 is about 0.035 in (or about 0.020 in-0.050in, 0.025 in-0.045 in, 0.030 in-0.040 in, etc.) such that the slot widthis larger than the filament to minimize or eliminate deformation and/ordenting on the fastener's filament during deployment, and smaller thanthe fastener's bar to prevent the bar from unintentionally coming out ofthe needle's lumen.

FIG. 99A shows another embodiment of a slotted needle 9900 that iscurved (not straight) where the needle tip 9902 is on the outside of thecurvature and the slot 9904 is on the inside of the curvature. FIG. 99Bshows another embodiment of a slotted needle 9906 that is curved wherethe needle tip 9908 is on the inside of the curvature and the slot 9910is on the outside of the of the curvature.

FIG. 100A-B show an embodiment of a slotted needle 10000 (FIG. 100A)comprising non-sharp edges 10002 (FIG. 100B) such as broken edges,radiused edges, polished edges, etc. for a length of the slot such thatthe non-sharp slot edges do not slice, cut or damage the fastener'sfilament during deployment.

Additional Embodiments of Devices and Methods to Fasten Onlay Material

FIG. 77 shows an embodiment of a device 900 containing two deploymentneedles 902. Both needles pierce the onlay material 904 (e.g., ADM) andtissue 906. Each needle deploys one bar 908 of the fastener in tissue asshown in FIG. 78 . The filament 910 holds and approximates and/orcompresses the onlay material to tissue as shown in FIG. 79 .

FIG. 80 shows an embodiment of a device 912 containing one deploymentneedle 914. In FIG. 81 , the needle pierces the onlay material 904(e.g., ADM) and tissue 906 at a first location 916 and deploys the firstbar 918 in tissue. In FIG. 82 , the needle is withdrawn from the firstlocation 916, pierces the onlay material and tissue at a second location920, and deploys the second bar 922 in tissue. The filament 924 holdsand approximates and/or compresses the onlay material to tissue as shownin FIG. 83 .

Embodiments of Devices and Methods Allowing Interrupted Suture

The following concepts illustrate how the fastener could be used inother device platforms to deliver a fast, interrupted stitch for joiningtwo or more tissues.

FIG. 84 shows an embodiment of a device 1000 with opposing jaws. Thefirst jaw 1002 has a slotted needle 1004 (to deploy the fastener), andthe second jaw 1006 has an opening or slot 1008 at the end of the jaw.

In FIG. 85 , the user targets the fixation location on the first tissue1010 (or other material) using the needle tip, then closes the opposingjaws 1002, 1006, so the needle punctures the first tissue at the targetfixation location and moves through the opening 1008 at the end of thesecond jaw 1006.

In FIG. 86 , the user opens the opposing jaws 1002, 1006, keeping thefirst tissue 1010 on the needle.

In FIG. 87 , with the first tissue 1010 on the needle, the user can movethe device to approximate the first tissue 1010 to the second tissue1012 (or other material). The user targets the fixation location on thesecond tissue using the needle tip, then closes the opposing jaws 1002,1006, so the needle punctures the second tissue at the target fixationlocation and moves through the opening 1008 at the end of the second jaw1006.

In FIGS. 88 and 89 , the user deploys the fastener's first bar 1014 andfilament 1016 through both tissues so the first bar 1014 and second bar1018 holds/fixes/approximates the second tissue 1012 and first tissue1010, respectively, together.

In FIG. 89 , the user opens the opposing jaws to remove the needle anddevice from the fixation site, leaving the tissues approximated andfixed together by the fastener. The user repeats the process for thenext fixation site.

The benefit of this platform over existing methods is the ability forthe user to quickly approximate tissues and/or materials and fix themtogether with an interrupted fixation using only one hand or without theneed of an assistant.

The opposing jaws could be joined by a single hinge (e.g. to close likescissors/hemostats). The opposing jaws could also be joined by multiplehinges (e.g. to close like parallel jaw pliers).

In some embodiments, the device shown in FIGS. 84-89 comprises featuresdescribed with respect to other embodiments of fastening devicesdescribed herein. For example, in some embodiments, the device comprisesone or more ramps (e.g., as described with respect to FIGS. 38-420 )configured to reorient a portion of the fastener (e.g., the second bar)as it is being deployed. Examples also include features (such as FIGS.23-26 and FIGS. 28-31 ) that could assist with keeping the tissue on theneedle, and/or allow the user to lift the tissue away from underlyingstructures and deploy the fastener without unintentionally fasteningunderlying structures.

FIG. 90 shows an embodiment of a device 1020 containing two deploymentneedles 1022. As shown in FIG. 91 , one of the deployment needlespierces a first tissue 1024. In FIGS. 92 and 93 , the device is moved toapproximate the first tissue 1024 to a second tissue 1026 by piercingthe second tissue with the other deployment needle. In FIG. 94A, eachneedle deploys one bar 1028 of the fastener through/in tissue. In FIG.94B, the filament 1030 holds and approximates and/or compresses thetissues together. The device could also incorporate any embodimentdescribed in this document to facilitate the procedure. Examples includefeatures (such as FIGS. 23-26 and FIGS. 28-31 ) that could assist withkeeping the tissue on the needle, and/or allow the user to lift thetissue away from underlying structures and deploy the fastener withoutunintentionally fastening underlying structures. For another example, insome embodiments, the device comprises one or more ramps (e.g., asdescribed with respect to FIGS. 38-420 ) configured to reorient aportion of the fastener (e.g., the second bar) as it is being deployed.

The benefit of this platform over existing methods is the ability forthe user to quickly approximate tissues and/or materials and fix themtogether with an interrupted fixation using only one hand or without theneed of an assistant.

Embodiments of Features Allowing Robotic Control

In some embodiments, the fastening devices and mechanisms describedherein can be configured to function under robotic control. It will beappreciated that any embodiment or combination of embodiments andfeatures described herein can be utilized in robotic applications.

In the handled embodiments of the fastening device described above, thefastener manipulation and deployment occurs within the distal end of thedevice. The proximal handle provides the required interface/motion forconveying fasteners within the shaft and transitioning the fastener tothe distal end where the fastener is manipulated into the needle or fangfor deployment.

For surgical robotic applications, rather than the robot holding thefastening device by the handle and squeezing the trigger like a surgeon,the device's distal end is converted to an end effector (which couldinclude the transition elements), and the handle's mechanistic action isreplaced with functions basic to a surgical robotic arm.

FIG. 158 shows the end effector 15810 attached to the surgical robot15812. Using a combination of rotation 15816 and articulation 15818, thesurgical robot can position the end effector, and in combination withother robotic tools (e.g. forceps) as needed, position and pierce themesh (or vice versa) over the tissue before deploying the fastener.

FIG. 159 compares embodiments of the path the fastener takes as it movesfrom conveyance to deployment within the handled and robot end effectorversions of the fastening device. In some embodiments, the end effectorfunctions to transition the fastener from conveyance and manipulate it,preparing it for deployment. As previously described, the conveyance cancomprise multiple configurations and hold as few as one and up to asmany fasteners desired.

A unique aspect to the robot interface can be replicating the cyclicaction of the handle mechanism to convey and transition the fastenerfrom a conveyance reservoir to the end effector, preparing the fastenerfor another element that deploys the fastener. In some embodiments, theconveyance advancer 15814 advances in increments of approximately thesame length as the length of the fastener. The increments can be longenough to transition the fastener from the conveyance reservoir to alocation in front of the deployment element 15813. The conveyanceadvancer 15814 is held in place to prevent other fasteners in queue fromadvancing prematurely and jamming the mechanism before the deploymentelement 15813 is activated. Once activated, the deployment element 15813pushes the fastener through the end effector, manipulating thefastener's configuration before moving the fastener through theneedle/fang, onlay material (e.g., mesh), into the tissue and releasingfrom the needle/fang. The deployment element 15813 can start and stopduring deployment but must be completely extended prior to retraction,to ensure the fastener is fully deployed and the transition zone isclear and ready to repeat the cycle.

FIG. 160 illustrates a quick connect between the proximal end 16024 of afastener end effector and distal end of a surgical robot 16020. Thedistal end of the surgical robot controls the end effector position(e.g., moving in, moving out, rotation and articulation) and internalpush/pull control rods to replicate the fastener handle motions todeploy the fastener.

The fastening device's proximal end has the necessary features toquickly connect the fastening device to the surgical robot. The internalpush/pull rods in the fastening device 16021 are oriented and advancedto capture the mating features on the push/pull rods 16023 in thesurgical robot 16020. The fastening device is then rigidly fixed to therobot by advancing the clamping collar 16025 over the device end 16024and threaded onto the robot 16020 (FIG. 162 ). Additionalinterface/indexing features, such as pin/hole and or slot/key, forexample, can be used for improved control/rigidity. In some embodiments,hollowing features to pass other mechanical/electrical/fluid interfacesor supply lines (e.g. additional fasteners) are utilized.

Removing the fastening device for a quick exchange requires the robot toposition the control rods 16023 for release (“home”), unscrew thethreaded collar 16025, and pull the fastening device off the end.

FIGS. 163-165 illustrate a more detailed view of an embodiment of aninterface between the robotic device and the push/pull rods 16021 of thefastening device. Orienting and approximating the push/pull rods on thefastening device to the robot moves the ball portion of the connectingrod 16023 and spreads the connecting clamp 16052 (FIG. 163 ). As thefastening device is advanced toward the robot, the connecting rodadvances into the connecting clamp pivots within the tube in thefastening device 16024 capturing the connecting rod 16023 (FIG. 164 ).When connected to the robot, the push rod/clamp assembly is pushedfarther into the fastening device, establishing the control rodconnection that the robot can use to replicate the handle mechanisticaction to advance and deploy the fastener.

In some embodiments, the robotic conveyance section (that stores theplurality of fasteners) comprises a quick change interface, allowing thesurgeon to replace an empty fastener cartridge with a new, fullcartridge.

In some embodiments, the fastener cartridge is replaceable with/withoutthe need to remove the fastening device from the robot. The conveyancesection of the device holds the fasteners where they are moved alongtoward the transition area and deployed. In some embodiments, theconveyance section (e.g., cartridge) is removeable. When the fastenersupply is exhausted, instead of having to remove/replace the fasteningdevice from the robot, the conveyance cartridge can be removed andreplaced. As shown in FIG. 166 , the conveyance cartridge 16081 isfilled with fasteners. The cartridge can have the features to lock thecartridge into the device housing 16080.

Referring to FIG. 167 , the cartridge 16081 is inserted into the devicehousing. Guides ensure the cartridge lines up with features in thetransition zone of the fastening device. Referring now to FIG. 168 , thecartridge interface can be spring loaded to lock the cartridge 16081 inplace and ensure the deployment and conveyance push rods (from proximalend of fastener) are aligned to move the fasteners into the transitionzone and deploy the fastener.

In some embodiments, the conveyance reservoir, conveyance advancer, anddeployment elements are flexible. The conveyance cartridge can be madefrom flexible plastics such as high and low density polyethyleneallowing it to flex within the fastener head and with the transition anddeployment zones as the head is articulated.

Additional Embodiments of Fastening Devices

In some of the embodiments disclosed herein a target material to bejoined to another material (e.g., ADM) is held against a backstop orother portion of the component while a fang or staple is inserted intothe target material. Stabilizing the target material in this mannerallows for the insertion of a staple into tough material like ADM.Currently, only suture is used in tough materials like ADM. Devices andmechanisms such as those described herein allow for stapling devices tobe used to join ADM during surgical procedures.

FIGS. 101A-1G show embodiments of a device configured to grasp and joinmaterial such as tissue or ADM. As shown in FIG. 101A, the device 10100comprises a housing 10102, a push rod 10104, and linkages 10106. FIG.101B shows pincers 10108, which are each connected to a linkage 10106 bya hinge. When the housing 10102 is advanced, as shown in FIG. 101C, thepincers 10108 close and grasp the first target material (e.g., ADM). Thedevice 10100 can be used to position the material as needed. The pincers10108 can be opened, placed on the second target tissue or material andactuated to pierce the two target materials. After the pincers 10108have pierced the two materials, the entire device 10100 may bemaneuvered to retract the materials in order to avoid underlyingstructures during staple deployment.

Then the push rod 10104 is advanced, the staple legs track along thepincer grooves 10110, shown in FIGS. 101D and 101E, causing the staple10112 (FIG. 101F) to close and fix the target materials to one another.The pincers 10108 can also serve as a guard to prevent the staple legsfrom grabbing unintended material during staple formation. Additionalpincer actuation may be applied to close the staples even smaller,thereby increasing the compression on the joined materials, if desired.

FIG. 101G shows another embodiment of a device 10100, in which the tipsof the pincers 10108 meet after actuation. This ability can improve thepincers' grasp on materials (e.g., when pulling tissue or ADM away froman underlying structure).

In some embodiments, the mechanisms shown in the device 10100 arelocated at the end of a shaft to facilitate access to confinedlocations.

FIGS. 102A and B show a device 10200 comprising a head 10202 located atthe end of shaft 10201. Carriers 10204 extend (e.g., upon actuation)from head 10202. As shown in FIG. 102C, tongs 10206 can be actuated anddeployed from the carriers 10204 to grasp target material(s) so that auser can position the material(s) if needed. Once the material(s) arepositioned, the tongs 10206 can be retracted, the carriers 10204 placedagainst the material, and the tongs 10206 actuated to pierce thematerial(s), as shown in FIG. 102D. As shown in FIG. 102E, while thetongs 10206 maintain their piercing through the material(s), thecarriers 10204 are retracted, positioning the material(s) against thehead 10202. The device 10200 may be maneuvered to retract thematerial(s) in order to avoid underlying structures during stapledeployment. As shown in FIG. 102F, the staple 10208 is deployed to fixthe materials to one another. The tongs 10206 also serve as a guard toprevent the staple legs from grabbing unintended materials during stapleformation.

FIGS. 103A-H show an embodiment of using a device 10300 with clampingjaws, a hook 10304 (e.g., a flexible hook, a nitinol hook) configured todeploy from a lower jaw 10308, and staples 10306 that deploy from anupper jaw 10310. As shown in FIG. 103A, the hook 10304 resides in thelower jaw 10308 while the device is inserted to the surgical site. FIG.103B shows the upper jaw 10310 clamping down on the target material10312 (e.g., ADM or tissue). FIG. 103C shows the hook 10304 actuated,and the target material secured to the device. FIG. 103D shows the upperjaw 10310 opened to allow positioning of the target material to thesecond target material 10314 (to be joined). In FIG. 103E, the twomaterials are positioned together (e.g., ADM positioned on tissue). FIG.103F shows the upper jaw 10310 clamping both materials. As shown in FIG.103G, the staple 10306 is deployed to fix the materials together. Thelower jaw 10308 also serves as a guard to prevent the staple legs fromgrabbing unintended material during staple formation. FIG. 103H showsthe hook 10304 being retracted, allowing movement or removal of thedevice 10300.

FIG. 104 illustrates an embodiment of an upper jaw 10400 comprising awindow 10402. The frame 10404 around the window 10402 serves to clampthe materials to be joined (e.g., ADM and tissue) between the upper andlower jaws. A staple 10406 is shown in the upper jaw 10400 near thewindow 10402. The clamping keeps the materials tensioned for the hook topenetrate through the materials and window.

FIG. 105A-G show an alternate embodiment of a device 10500 with clampingjaws, a rigid hook 10504 (instead of a flexible (e.g. nitinol) hook)attached to the lower jaw 10502 by a hinge 10506, and staples 10508 thatdeploy from an upper jaw 10510. FIG. 105B shows the upper jaw 10510clamping down on the target material 10512 (e.g. ADM or tissue). FIG.105C shows the rigid hook 10504 actuated, and the target materialsecured to the device. FIG. 105D shows the upper jaw 10510 opened toallow positioning of the target material to the second target material10514 (to be joined). In FIG. 105E, the two materials are positionedtogether (e.g. ADM positioned on tissue). FIG. 105F shows the upper jaw10510 clamping both materials and the staple 10508 deployed to fix thematerials together. The lower jaw 10502 also serves as a guard toprevent the staple legs from grabbing unintended material during stapleformation. FIG. 105G shows the rigid hook 10504 retracted, allowingmovement or removal of the device 10500.

FIGS. 106A-108B show an embodiment of a device that can be used tosecure and stabilize a first material and second material to be joined.Such a device can be particularly useful to position and stabilize toughmaterials (like ADM) for staple penetration. An integrated or separate(e.g., currently available) stapler or stapling mechanism can be used toperform the stapling to fix the materials together.

FIGS. 106A and 106B show views of the device 10600 comprising a needle10602 (or other piercing member) attached to a first jaw 10604. Thesecond jaw 10606 comprises an opening hole 10608. The needle 10602 andhole 10608 are positioned and configured such that the needle 10602enters the hole 10608 when the jaws 10604, 10606 are closed, as shown inFIG. 106B.

FIGS. 107A-H illustrate an embodiment of a method of using the device ofFIGS. 106A-B to fix a first material 10702 (e.g., ADM) to a secondmaterial 10704 (e.g., tissue). FIG. 107A shows the needle tip 10706being used to target the fixation location on the first material 10702.As shown in FIG. 107B, the jaws 10604, 10606 are closed, causing theneedle 10602 to puncture the first material by entering the hole in thesecond jaw (not shown). In FIG. 107C, the jaws 10604, 10606 are opened.As shown in FIG. 107D, the first material 10702 is positioned to thedesired fixation location on the second material 10704 using the needle10602, and the needle tip 10706 is used to target the fixation locationon the second material 10704. In FIG. 107E, the jaws 10604, 10606 areclosed, compressing the second material 10704 onto the needle tip 10706by inserting the needle 10602 into the hole of the second jaw. Theentire device 10600 may be maneuvered to retract the materials in orderto avoid underlying structures during staple deployment. FIG. 107F showsthe stapling mechanism 10708 telescoping to the fixation site anddeploying the staple 10710 to fix the target materials to one another.As shown in FIG. 107G, the stapling mechanism 10708 is retracted. Thejaws 10604, 10606 are opened, and the device 10600 is removed, as shownin FIG. 107H. In some embodiments, the device 10600 is modified so thatthe needle has a channel for the staple leg to travel and pass easilythrough the first material (e.g. tough ADM) and second material.

FIGS. 108A and 108B show an alternate jaw embodiment with two opposingsharp tips 10802. The tips 10802 can be used to position the firsttarget material 10806 to the second target material 10808 and can thenbe used to puncture the first material and secure the second material,as shown in FIGS. 108C and 108D. The entire device 10800 may bemaneuvered to retract the target materials (e.g., ADM and tissue) inorder to avoid underlying structures during staple deployment. Thestapling mechanism telescopes to the fixation site and deploys thestaple to fix the materials. The device could be modified so the eachsharp tip has a channel for the corresponding staple leg to travel andpass easily through the first material (e.g. tough ADM) and secondmaterial. The tips could also be modified to serve as a guard to preventthe staple legs from grabbing unintended material during stapleformation.

FIGS. 109A and 109B show an embodiment in which the staple 10902 ismounted on the end of a shaft 10904. The staple 10902 can be curved,with one end mounted to the end of the shaft 10904 and the sharp endfree from the shaft. The staple can be curved within a plane that isperpendicular (or at some angle) to the shaft 10904. This positioningcan allow rotation of the shaft to drive the staple through adjacentmaterial(s).

An example application for such a device is shown in FIG. 110A where thestaple and shaft are inserted into an incision 11008. In FIG. 110B, thestaple and shaft are inserted to the location where the ADM is to beattached to tissue. In FIG. 110C, the shaft drives the staple throughthe ADM and tissue. Prior to closing the staple, the entire device maybe maneuvered to lift the tissue/ADM and check if underlying structureswere grabbed unintentionally. In FIG. 110D, a fork 11008 advances aroundthe staple tip. In FIG. 110E, the shaft and fork actuate to bend andclose the staple. In FIG. 110F, the device is removed, and the closedstaple secures ADM to tissue.

A device with this configuration could also be used to place a stapleaway from the edges of the target material (e.g., ADM). In FIG. 110G,the staple 10902 pierced through ADM 11002 and tissue 11004. The fork11008 was used as a backstop on top of the ADM to apply countertractionso the staple tip can penetrate back up through the ADM 11002. Prior toclosing the staple, the entire device may be maneuvered to lift thetissue/ADM and check if underlying structures were grabbedunintentionally. In FIG. 110H, the shaft and fork actuate to bend andclose the staple 10902, securing the ADM 11002 to tissue 11004 as shownin FIG. 110I.

Alternatively, the staple 10902 could pierce through ADM 11002 andtissue 11004 without piercing back up through the ADM 11002, as shown inFIG. 110J. Prior to closing the staple, the entire device may bemaneuvered to lift the tissue/ADM and check if underlying structureswere grabbed unintentionally. The staple 10902 leg above the ADM 11002could then be bent to fix the ADM 11002 to tissue 11004, as shown inFIGS. 110K and 110L.

FIGS. 111A and 111B show another embodiment in which the staple 11102 ismounted on the end of a shaft 11104. The shaft 11104 can comprise 2 rods11106, each rod connected to a side of the staple. This architecturecould be used to place a staple on the edges of the target material(e.g., ADM) or away from the edges of the target material (e.g., ADM).

The staple tips are placed on the ADM/tissue 11108, as shown in FIG.111C. The rods 11106 of the shaft 11104 are rotated to close the staple11102, as shown in FIG. 111D. The staple can then be released from therods. This can be performed using a variety of methods (e.g., a push rodpushing the staple off the shaft, a spring that pushes the staple offthe shaft, etc.).

FIG. 112 illustrates an alternate mechanism that closes the staple11202. The staple span rests on die 11204. Dies 11206 are actuatedtoward die 11204 causing the staple 11202 to close.

FIG. 113A shows an embodiment of a staple 11302 with tip 11304 andpre-formed features 11306. FIG. 113B shows the staple 11302 held by afirst jaw 11308. FIG. 113B also shows slot 11310 in a second jaw 11312such that the staple tip 11304 enters the slot 11310 when the jaws11308, 11312 are closed.

The staple tip 11304 is used to target the fixation location on thetarget material 11314 (e.g., ADM). The jaws 11308, 11312 are closed,causing the staple tip 11304 to puncture the ADM 11314 by entering theslot 11310 in the second jaw 11312, as shown in FIG. 113C. The ADM 11314is moved inside the pre-formed staple features 11306 by sliding thestaple through until the ADM is positioned within the pre-formed staplefeatures, as shown in FIG. 113D. The jaws 11308, 11312 are opened, theADM 11314 is moved into position, and the staple tip 11304 is used totarget the fixation location on tissue as shown in FIG. 113D. In FIG.113E, the jaws 11308, 11312 are closed, causing the staple tip 11304 topierce tissue. The tissue 11316 is compressed onto the staple 11302 asthe staple tip 11304 enters the slot 11310 of the second jaw 11312. Theentire device may be maneuvered to lift the tissue/ADM and check ifunderlying structures were grabbed unintentionally.

With the staple leg in the slot of the second jaw 11312, the second jaw11312 is rotated to close the staple (FIG. 113F) and fix the ADM totissue. The pre-formed staple features and the closed staple leg securethe ADM to tissue as shown in FIGS. 113G and 113H. In some embodiments,the pre-formed staple feature(s) may differ from that shown in FIGS.113A-H, so long as the pre-formed feature serves to prevent the targetmaterial (e.g., ADM) from disconnecting from the staple. Examples couldinclude a barb or barbs (FIG. 1131 ) or a stopper feature (FIG. 113J).

FIG. 114A shows another embodiment of a staple 11402 with a staple tip11404 and pre-formed features 11406. The staple 11402 is held by a firstjaw 11408, as shown in FIG. 114A. A second jaw 11410 comprises a hole11412 and an anvil 11414, as shown in FIGS. 114B and 114C. As shown inFIG. 114B, the hole 11412 can be positioned distal to the anvil 11414,in some embodiments. Alternatively, the anvil 11414 can be positioneddistal to the hole 11412, as shown in FIG. 114C.

FIGS. 115A-G show an embodiment of a method of using the staple 11402and jaws 11410, 11408, described with respect to FIGS. 114A-C. Thestaple tip 11404 is used to target the fixation location on the targetmaterial 11502 (e.g., ADM). As shown in FIG. 115A, the jaws 11408, 11410are closed, causing the staple tip 11404 to puncture the ADM 11502 byentering the hole 11412 in the second jaw 11410. In FIG. 115B, the jaws11408, 11410 are opened, and the second jaw 11410 is actuated to alignthe anvil 11414 with the staple tip 11404. The ADM 11502 is positioned,and the staple tip 11404 is used to target the fixation location on thesecond target material 11504 (e.g., tissue).

In FIG. 115C and FIG. 115D, the jaws 11408, 11410 are closed,compressing tissue 11504 onto the staple tip 11404 and sending thestaple tip 11404 into the anvil 11414 on the second jaw 11410. Theentire device may be maneuvered to lift the tissue/ADM and check ifunderlying structures were grabbed unintentionally. In FIG. 115E, thejaws 11408, 11410 continue to close, causing the anvil 11414 tocurl/close the staple leg 11506 and fix the ADM 11502 to tissue 11504.The anvil 11414 also serves as a guard to prevent the staple leg fromgrabbing unintended material during staple formation. FIG. 115F showsthe staple 11402 in place with the jaws withdrawn.

FIGS. 116A and 116B illustrate an alternative embodiment for closing thestaple. In the first jaw 11602, an element 11604 (such as a wedge orother mechanism) is actuated. This advances the staple within the firstjaw towards the anvil (where the anvil is in the second jaw), causinganvil to curl/close the staple leg and fix the ADM to tissue. Thismechanism could be used solely on its own to close the staple, or itcould be used in conjunction with closing the jaws as described in FIG.115 .

FIG. 117 shows an alternative embodiment of a staple 11802 withpre-formed features 11806 and a pre-bent tip 11804 that enables thestaple leg to bend in the proper direction in the anvil (instead ofjamming or buckling in the anvil).

FIGS. 118A-C show an alternative embodiment of a staple 11902 withpre-formed features 11904 and a pre-bent tip 11906 that enables thestaple leg 11908 to bend in the proper direction in the anvil (notshown). This pre-bent tip 11906 can help prevent jamming or buckling inthe anvil. Staple closing is accomplished by bending the distal end orleg 11908 in the anvil, as shown in FIG. 118B, and bending the proximalend or leg 11910 with a plunger or other mechanism, as shown in FIG.118C.

FIGS. 119A-C show an alternative embodiment of a staple 12002 containingmultiple pre-bends 12004 on the distal leg 12006 and multiple pre-bends12008 on the proximal leg 12010. Staple closing is accomplished bybending the distal end or leg in the anvil and bending the proximal endor leg with a plunger or other mechanism. The staple 12002 is shown inits closed configuration in FIG. 119C.

FIG. 120 illustrates a shroud 12102 with a sharpened tip 12104 attachedto a jaw 12106. The staple 12108 resides in the lumen 12110 of theshroud. The sharpened shroud tip facilitates penetration through atarget material (e.g., ADM). The shroud 12102 provides rigidity for thestaple 12108. This design mitigates undesired staple leg bending ordeforming from user applied forces (e.g. that may cause the staple legto miss the staple forming features on the second jaw, or that may causeimproper staple closing). The shroud slot 12112 allows the staple toclose. The staple may or may not have a sharpened tip. The rigid shroudcould also allow for smaller staples since the shroud takes the userapplied forces instead of the staple.

FIGS. 121A-C show various views of an embodiment of a device 12200 withstaple 12202 with staple barb 12204 residing in a first jaw 12206. Asshown in FIG. 121A, a first end of the staple is bent at an angle,causing it to extend towards the exit of the first jaw. The first jawcomprises a forming feature 12208. The device also comprises slidingforming member 12210, push rod 12212, stop 12214, cover (transparent toenable visibility of internal features), and second jaw 12216. FIG. 121Cshows the hole 12218 in the second jaw 12216.

FIGS. 122A-M show an embodiment of a method of using the device 12200 ofFIGS. 121A-C. The device 12200 is inserted to the surgical site with thestaple tip residing in the lower jaw 12206. As shown in FIG. 122A, thepush rod 12212 is advanced until the staple barb 12204 contacts the stop12214, causing the staple tip 12220 to extend out of the first jaw12206.

FIGS. 122B and 122C show the sliding forming member 12210 advanced,causing the staple tip to bend by pressing the staple 12202 against theforming feature 12208. FIG. 122B shows a schematic view of the device12200, such that the internal components are visible, while FIG. 122Cshows the device being used in a procedure, such that the internalcomponents are not visible. Alternatively, the staple tip bendingdescribed above could be done prior to inserting to the surgical site,and the second jaw could be closed to conceal the staple tip while thedevice is inserted to the surgical site.

FIGS. 122D and E show the staple tip 12220 being used to target thefixation location on the target material 12304, in this case, ADM. Thenthe jaws 12206, 12216 are closed, causing the staple tip 12220 topuncture the ADM 12304 by entering the hole 12218 in the second jaw12216.

As shown in FIGS. 122F and G, the stop 12214 (contacting the staplebarb) is disengaged. The jaws 12206, 12216 are then opened. The targetmaterial, in this case, ADM, is positioned to the second target material12306 (e.g. tissue). The staple tip 12220 is used to target the fixationlocation on the second target material 12306. FIG. 122F shows aschematic view of the device 12200, while FIG. 122G shows the device12200 while it is performing a stapling procedure.

In FIGS. 122H and 1221 , the jaws 12206, 12216 are closed, compressingtissue 12306 onto the staple tip 12220. The entire device may bemaneuvered to retract the tissue/ADM in order to avoid underlyingstructures during staple deployment. FIG. 122H shows a schematic view ofthe device 12200, while FIG. 122I shows the device 12200 while it isperforming a stapling procedure.

In FIGS. 122J and 122K, the push rod 12212 is advanced. When the slidingforming member 12210 is in its forward position, it bends the staple bycompressing it against the forming feature 12208 in the first jaw 12206.As the push rod 12212 advances the staple, the compression zone (createdby the forming feature 12208 and the sliding forming member 12210)continuously deforms the staple as the staple advances through thecompression zone, causing the staple to curl. The curled staple fixesthe ADM 12304 to tissue 12306. The second jaw 12216 also serves as aguard to prevent the staple leg from grabbing unintended material duringstaple formation. FIG. 122J shows a schematic view of the device 12200,while FIG. 122K shows the device 12200 while it is performing a staplingprocedure.

FIGS. 122L and 122M show the staple 12202 after release from the device12200. FIG. 122L shows a schematic view of the closed staple 12202,while FIG. 122M shows the closed staple 12202 after performing thestapling procedure.

FIGS. 123A and 123B show a portion of a device 12400 with staple 12402residing in fangs 12404. The fangs 12404 are part of a head 12410portion of the device. The device 12400 also comprises a retractablebackstop 12406. The backstop 12406 has holes 12408 that are shaped toaccept the fangs 12404. The backstop 12406 retracts relative to thefangs 12404 of the device. When it is retracted, the backstop 12406moves proximally relative to the fangs 12404 (shown best in FIG. 124E).Using the backstop with holes shaped to accept the piercing element(e.g., the fangs), allows the device to pierce a tough material, such asADM, without having to apply high force or pressure to the tissue. Insome embodiments, the staple itself can function as the piercingelement.

FIGS. 124A-L show an embodiment of a method of using device 12400 shownin FIGS. 123A and 123B. FIGS. 124A and B show the device 12400maneuvered so that a target material to be joined 12502 (e.g., ADM) ispositioned between the fang 12404 and its associated backstop hole12408. The fang 12404 is used to target the fixation location on the ADM12502. The backstop 12406 is then actuated to push the ADM 12502 ontothe fang 12404. Similar to FIGS. 122A-L, FIG. 124A shows a schematicview of the device 12400, while FIG. 124B shows the device while it isperforming a stapling procedure.

FIGS. 124C and 124D show the backstop 12406 opened to disengage from thefangs 12404, causing the holes 12408 to be withdrawn from the fangs12404. FIG. 124C shows a schematic view of the device 12400, while FIG.124D shows the device while it is performing a stapling procedure.

FIGS. 124E and 124F show the backstop 12406 being retracted, such thatit is moved proximally relative to the fangs 12404, exposing fangs12404. FIG. 124E shows a schematic view of the device 12400, while FIG.124F shows the device while it is performing a stapling procedure.

In FIGS. 124G and 124H, the fang 12404 was used to target the fixationlocation on the second target material, in this case, tissue 12504, andposition the ADM 12502. The fangs 12404 are then inserted into tissue12504. The length of the fangs 12404 is sized to penetrate tissue 12504to a certain depth. The fangs 12404 prevent the staple 12402 fromgrabbing/damaging underlying structures.

FIGS. 1241 and 124J show the staple 12402 being formed. The span of thestaple 12402 rests on a center die 12510. The outer dies 12508 areactuated to bend the staple on center die 12510. Actuating the outerdies 12508 comprises moving them in the direction indicated by the arrowin FIGS. 1241 and 124J. The staple legs 12506 bend inward to gather,compress and fix the ADM to tissue.

The staple could also be deployed in stages. In the first stage, shownin FIG. 1241 , the staple 12402 grasps ADM 12502 and tissue 12504. Priorto fully closing the staple, the device may be maneuvered to retract thetissue/ADM in order to avoid underlying structures prior to fullyclosing the staple. While holding the tissue/ADM away from underlyingstructures, the staple can be fully closed, as shown in FIG. 124J.

In FIG. 124K, the staple comes off of the center die and is detachedfrom the stapler. Ejectors could assist with pushing the staple off thecenter die.

An alternative method for using the device described in FIGS. 123A-124Kis excluding the use of the backstop by piercing the onlay material andunderlying tissue directly with the fangs such that the fangs piercethrough the onlay material and into the underlying tissue. The staplecan then be fully deployed and closed as described in FIGS. 124I-124J.The staple could also be deployed in stages. In the first stage, shownin FIG. 1241 , the staple 12402 grasps ADM 12502 and tissue 12504. Priorto fully closing the staple, the device may be maneuvered to retract thetissue/ADM in order to avoid underlying structures prior to fullyclosing the staple. While holding the tissue/ADM away from underlyingstructures, the staple can be fully closed, as shown in FIG. 124J.

In some embodiments, the device 12400 comprises a staple reservoir 12600shaped and configured to hold a plurality of staples, as shown in FIG.125 . The staple reservoir 12600 can be fixed to the stapler device12400 or could be a replaceable cartridge.

FIG. 126 shows an embodiment of a device 12700 comprising a stapler head12702 similar to the structure shown in FIG. 125 . The stapler head12702 is positioned at a distal end of a shaft 12704 which enablesstaple placement in confined locations. The device 12700 comprises ahandle 12706 and actuator 12708, which can be used to control thefunction of the stapling mechanism.

FIGS. 127A and 127B show an embodiment of a device 12800 with one fang12802 on a rotating head 12804 to enable staple placement on, forexample, both sides of a breast implant and/or in confined locations.FIG. 127A shows the device 12800 with the rotating head positioned sothat the fang 12802 is on a first side of the device 12806. FIG. 127Bshows the device 12800 with the rotating head rotated about 180°, suchthat the fang 12802 is on a second side of the device 12806. The headcan also rotate through a range of angles.

FIGS. 128A-C show an embodiment of a device 12900 with an articulatinghead 12902. The articulating head 12902 can enable staple placement inconfined locations. The head 12902 can articulate, in some embodiments,by rotating around hinge point 12904. FIGS. 128A-C show the head 12902articulated through a first, second, and third position, respectively.

In the embodiments of staple formation described herein, as shown moreclearly in FIGS. 129A and 129B, the fang 13004 and staple 13002 stretchthe hole 13006 in the target material 13008 (e.g., ADM) as the staple13002 forms. The stretching hole 13006 resists the closing staple. Insome embodiments, the devices or mechanisms comprise further features toenhance or improve staple formation.

FIGS. 130A-C show a device 13100 with retractable fangs 13102. When thestaple 13104 starts to clinch (the staple closing dies are not shown),the fangs 13102 retract, as shown in FIG. 130C. With the fangsretracted, the ADM can more easily comply with the forming staple leg.

FIGS. 131A-B show an embodiment of an optional feature that could existon a fang or device. In some embodiments, the fang 13202 comprises ablade 13204 that creates a slit 13208 in the fang hole 13206 (the holecreated by the fang in the target material). As shown the blade canextend along the length of the fang (e.g., at its shorter side), and cancomprise a tapered shape. When the staple forms, the staple leg 13210can enter the slit so that the leg can fully close. FIG. 131C shows atop view of an exemplary fang hole 13206 and slit 13208 created by thefang 13202 and blade 13204 combination of FIGS. 131A and 131B.

FIG. 132 shows an embodiment of fangs 13302 that articulate. The fangs13302 can serve to bend the staple tips 13304 inward and aide stapleclosing. The articulating fangs can also grasp two target materials tobe joined. The entire device may be maneuvered to retract the materialsin order to avoid underlying structures during staple deployment. Thefangs 13302 can also serve as a guard to prevent the staple legs fromgrabbing unintended material during staple formation.

FIGS. 133A and 133B show an embodiment of fangs 13402 comprisinginternal features configured to close a staple. The features also serveas a guard to prevent the staple legs from grabbing unintended materialduring staple formation. As shown in FIGS. 133A and 133B, the featurescan comprise a slanted edge or surface 13404 configured to urge thestaple leg 13406 inward upon moving the staple leg 13406 towards theedge or surface 13404. The features can further comprise another edge orsurface 13408, around which the staple leg 13406 is configured to bend,when urged in that direction and vicinity by the slanted edge or surface13404.

FIGS. 134A-C show fangs 13502 with adjustable positions. At a firstposition, shown in FIG. 134A, the fangs 13502 are concealed duringdevice insertion and removal to prevent injury to surroundingstructures. At a second position, shown in FIG. 134B, the fangs 13502are slightly exposed, set to penetrate tissue at a shallow depth. At athird position, shown in FIG. 134C, the fangs 13502 are further exposed,set to penetrate tissue at a deeper depth. The staple can be configuredto not extend past the tips of the fangs, thereby protecting underlyingstructures. Optional depth markers 13504 on the fangs can aid the userin setting the fangs at the proper length.

FIG. 135 shows an embodiment of a fang 13602 with external threads13604. When the fang is placed on top of a first target material 13606,such as ADM, and second target material 13608, such as tissue, the fang13602 is rotated to thread into the materials. The fang 13602 can berotated until the desired depth into the materials is attained, avoidingunderlying structures. With the threads engaged in ADM and tissue, thefang can be used to pull the ADM and tissue away to protect underlyingstructures during staple deployment.

FIGS. 136A-C show various embodiments of fangs 13702. FIG. 136A shows afang 13702 with barbs 13704 positioned along a length of the fang 13702.FIG. 136B shows a fang 13702 with a plurality of notches 13706positioned along a length of the fang 13702. FIG. 136C shows a fang13702 with a plurality of necks 13708 positioned along a length of thefang 13702. When the fang(s) is inserted into a target material to thedesired depth, the barbs, notches, and/or necks grip the targetmaterial. The fangs can be used to pull the material(s) away to protectunderlying structures during staple deployment.

In some embodiments, the fang tips have various sharpened tip designs,such as lancet tip, vet (reverse grind) tip, trocar tip, etc. Thesevarious tip designs can aid in ease of insertion through a toughmaterial, such as ADM.

In some embodiments, the fangs can be replaceable. For example, thefangs can be part of a replaceable staple cartridge, as describedherein. In other embodiments, the fangs are replaceable themselves,irrespective of the use of a cartridge.

FIG. 137 shows an embodiment of a fang 13802 that is configured to flip(or rotate, or snap, or articulate, etc.) down. The fang can beconfigured to be concealed within a head 13804 of a device to protectsurrounding structures. The fang 13802 can then be configured to flipdown when needed, as shown in FIG. 137 .

In some embodiments, the fang 13902 is covered by a shroud 13904 toprotect surrounding structures as shown in FIG. 138 . The shroud 13904is configured to retract when the fangs are needed.

In some embodiments, the fangs 14002 can be concealed in the backstopholes 14004, as shown in FIG. 139 . The backstop 14006 can be configuredto actuate and retract when the fangs 14002 are needed.

The embodiments described herein in which fangs are used to penetratethe target material can be adapted such that the staple legs perform thefunction of the fangs. In other words, the staple legs can be configuredto penetrate the target materials instead of the fangs, therebyeliminating the fangs.

FIGS. 140A and 140B show embodiments of staples with varying shapes. Thestaple 14102 of FIG. 140A has a more square shape, while the staple14102 of FIG. 140B has a more rounded shape. The radii on the staple14102 of FIG. 140B can enable the target material to slide more easilyalong the staple leg (e.g., to prevent snagging) during stapleformation.

In some embodiments, the stapler or the staple is configured such thatstaple formation results in one staple leg residing above the other leg,as shown in the front view of FIG. 141A. This configuration can helpprevent the staple legs from flaring out of plane, as shown in the topview of FIG. 141B.

After forming a staple and the forming dies are retracted, the staplelegs could spring open slightly, as shown in FIGS. 142A-D. FIGS. 143A-Cshow staple formation. In FIG. 142A, the forming mechanism 14302 ispositioned above the staple 14304 and center die 14306. In FIG. 142B,the forming mechanism is lowered onto the staple, bending the staplelegs 14308 around the center die 14306. In FIG. 142C, the formingmechanism 14302 is raised away from the staple 14304. Removing thecompressing force of the forming mechanism 14302 causes the staple legs14308 to spring open slightly. FIG. 142D shows another embodiment of astaple 14310 with the legs 14312 sprung open slightly.

FIG. 143A shows an embodiment of a staple 14402 with features to keepthe staple legs 14404 closed after the forming dies are retracted. Asshown in FIG. 143A, the staple 14402 comprises humps 14406, thegeometry, dimensions, and locations of which can be changed to tune thepositioned of the closed staple legs. FIG. 143B shows the staple 14402being compressed into a closed position by the dies 14408. FIG. 143Cshows the staple 14402 with the dies removed and the legs 14404remaining closed.

FIG. 144 shows another embodiment of a staple 14502, in which the staplelegs remain closed after the forming dies are retracted. The staple14502 comprises bumps 14504. The geometry, dimensions, and locations ofthe bumps can be changed to tune the position of the closed legs 14506.

In some embodiments, staples are made from resorbable materials.

The embodiments shown in FIGS. 123A-144 can allow a single user toapproximate an incision and place a staple. Currently, it could take upto two people to approximate and staple an incision: two hands to graspand approximate the tissue on both sides of the incision, and anotherhand to deploy the staple (total of three hands). One user could operatethe device described with respect to FIGS. 123A-124K to secure thetissue on side 1 of the incision in one fang, approximate it to thetissue on side 2 of the incision, secure the tissue on side 2 of theincision in the other fang, then deploy the staple.

FIGS. 145A-D show an embodiment of a single user using such a device. InFIG. 145A, a first 14602 and second 14604 material to be joined areshown. A fang (not shown) holds the first material 14602 at point 14606.FIG. 145B shows the materials as the device is used to approximate thematerials. The first and second materials 14602, 14604 are broughtcloser together. FIG. 145C shows the materials next to one another. Asecond fang (not shown) holds the second material 14604 at point 14608.FIG. 145D shows the materials 14602, 14604 after staple 14610 has beendeployed to join the materials 14602, 14604.

FIGS. 146A-D show a method of using a stapler (not shown) that forms thestaple legs 14702, 14704 at different times. FIG. 146A shows two piecesof material 14706, 14708 to be joined. As shown in FIG. 146B, thesurgeon could actuate the stapler to close one leg 14702 of the staplein one tissue 14706 (or material). As shown in FIG. 146C, the surgeoncan then move the stapler to approximate the tissues (or materials).FIG. 146D shows the materials 14706, 14708 after a second actuation ofthe stapler to close the other leg 14704 of the staple in the secondtissue 14708 (or material). This approach could be applied to a staplerwith fangs, or to a stapler without fangs that uses the staple legs toperform the function of the fangs.

FIGS. 147A-D illustrate another embodiment of a stapling mechanism 14800like that described with respect to FIGS. 101A-101G. FIG. 147A shows afirst arm 14802 with a first fang or pincer 14804, and first backstophole 14806. The stapling mechanism 14800 also comprises a second arm14808 with second fang or pincer 14810 and second backstop hole 14812.

FIG. 147B shows, the fangs 14804, 14810 are placed on the first targetmaterial 14814 (e.g., ADM) and used to target the fixation locations onthe ADM. The arms 14802, 14808 are actuated, folding the ADM. Thiscauses fang 14804 to pierce the folded ADM 14814 and enter backstop hole14812, and fang 14810 to pierce the folded ADM and enter backstop hole14806.

In FIG. 147C, the arms 14802, 14808 are opened, such that fang 14804pulls out of backstop hole 14812 and the corresponding location of ADM,and fang 14810 pulls out of backstop hole 14806 and the correspondinglocation of ADM. The ADM adjacent to the base of the fangs are stillattached to fang 14804 and fang 14810. In FIG. 147D, the ADM 14814 ispositioned, the fangs 14804, 14810 are used to target the fixationlocation on a second target material 14816 (e.g., tissue), and the fangs14804, 14810 are inserted into tissue. If the device has staple formingdies (e.g., as described with respect to FIGS. 112 and 124I-J), thestaple can be deployed to gather, compress and fix the ADM to tissue.The staple could also be deployed in stages (as described in FIGS.124I-J) to pull the tissue/ADM away and protect underlying structuresprior to closing the staple.

If the device uses the fangs to form the staple (e.g., as described withrespect to FIGS. 101A-101G), the arms 14802, 14808 are partiallyactuated, as shown in FIG. 147E. The device may be maneuvered to retractthe tissue 14816 and ADM 14814 to avoid underlying structures duringstaple deployment. In some embodiments, to cause staple closure, a pushrod is advanced to deploy the staple; the staple legs advance and trackalong the fang grooves, and the staple closes to gather, compress andfix the ADM to tissue. The fangs also serve as a guard to prevent thestaple legs from grabbing unintended material during staple formation.

FIGS. 148A-D illustrate embodiments of fangs comprising featuresconfigured to enhance performance of the device in FIG. 147 . Forexample, FIG. 148A shows an embodiment of a fang 14902 comprising anotch 14904 to better retain a material (e.g., ADM) at the fang's base.The fang 14902 also comprises a taper 14906 to enable the distal end ofthe fang 14902 to pull easily out of material, such as ADM. FIG. 148Bshows an embodiment of a fang 14902 comprising a lubricious coating14908, configured to allow the distal end of the fang 14902 to pulleasily out of material, such as ADM. The fang 14902 of FIG. 148B alsocomprises a notch 14904. FIG. 148C illustrates an embodiment of a fang14902 comprising a barb 14910 configured to better retain a material,such as ADM, at the fang's base. FIG. 148D shows an embodiment of a fang14902 comprising a neck 14912 configured to better retain a material,such as ADM, at the fang's base.

In some embodiments, the stapling mechanism can use an energy source toaid in the fang or staple piercing material, such as ADM. In someembodiments, high-frequency (e.g. radio frequency) electrical currentcan be applied to the fang or staple. In some embodiments, a laser canbe used to cut a hole in the material (e.g., ADM). In some embodiments,ultrasonic energy is applied to the fang or staple.

FIG. 149 shows a sheet 15000 of material (e.g., ADM) that has beenprepared with multiple holes 15002. The prepared holes 15002 remove theburden on the fang or staple from having to puncture through thetoughness of a material like ADM. With the prepared holes 15002, thestaple leg can easily pass through a hole.

FIG. 150A shows a bone anchor staple 15100 intended to fix soft tissue(or ADM, mesh, membrane, etc.) to bone. The bone anchor staple has astaple wire feature 15102 that extends from a bone anchor feature 15104.

This device 15100 could be utilized in procedures to simplify/eliminatecomplex suture management (e.g. arthroscopic rotator cuff repair). FIG.150B shows the bone anchor feature 15104 inserted into bone 15106 withthe staple wire feature 15102 protruding from the bone 15106. FIG. 150Cshows the material 15108 (e.g., tissue) pushed onto the staple wirefeatures 15102. FIG. 150D shows the formed staple wire features 15102securing the tissue 15108 to bone 15106.

FIGS. 151A and 151B show views of a stapler concept that has a shaft15202 keeping multiple spring staples 15204 open. The shaft 15202rotates and drives the staple 15204 through a material such as tissues(or ADM, mesh, membrane, etc.) that are to be fixed together. When thestaple comes off the end of the shaft, the staple 15204 contracts to asmaller size to gather, compress and fix the materials 15206, 15208together, as shown in FIG. 151C. The next staple is advanced to the endof the shaft and is ready to be deployed.

FIGS. 152A-C show an embodiment of a device 15300 that approximatesmaterials, such as tissues (or ADM, mesh, membrane, etc.) so a staplecan fix the tissues together. FIG. 152A shows textured wheels 15302,15304 where one wheel is in contact with tissue 15306 on one side of theincision 15308 (or gap). The other wheel 15304 is in contact with tissue15310 on the other side of the incision 15308 (or gap). The wheels15302, 15304 are rotated (as shown by the arrows) to gather the tissue.FIG. 152B shows the textured wheels 15302, 15304 after they have beenrotated, where the tissue 15306, 15310 from both sides of the incision15308 have been approximated between the wheels. FIG. 152C shows thestaple 15312 fixing the tissues 15306, 15310 together. The rotatingwheels could be a separate device from the stapler or integrated intothe stapler device.

FIG. 153A shows a polymer strand 15402 with a series of openings 15404at one end of the strand. A guide tube 15406 is used to puncture thematerials 15408 (e.g., tissues) that are to be fixed together. Thetissues could also be ADM, mesh, membrane, etc. The polymer strand 15402is advanced in the guide tube 15406 until the distal end 15410 of thepolymer strand 15402 goes through an opening 15404 in the strand.

As shown in FIG. 153B, a heating element fused the strand 15402 at theopening 15404 to create a fixed loop 15414 that compresses and fixes thetissues together. A slot 15416, shown in FIG. 153C, along the length ofthe inner loop of the guide tube 15406 allows the guide tube to beremoved, leaving the stitch. The excess length of polymer strand couldbe trimmed, leaving only the fixed loop/stitch.

FIGS. 154A-E show an embodiment of a device 15500 configured toapproximate and join tissue. As shown in FIG. 154A, the device 15500comprises a sharpened hollow or tube arm 15502 that is shown penetratingmaterial or tissue 15504. The material can be ADM, mesh, membrane, etc.FIG. 154B shows the arm 15502 being used to approximate the material15504 to the material 15506 to be joined. In FIG. 154C, sharpened arm15508 (tube arm, hollow arm) has penetrated material 15506 so that thetips of the arms 15502, 15508 mate. The tips can be shaped such thatthey are configured to mate with one another, forming the arms 15502,15508 into a loop. As shown in FIG. 154D, a material such as a heatedpolymeric material is injected into the lumen 15510 of the arms 15502,15508. As shown in FIG. 154E, the material cools and hardens to form afastener 15512. The arms are removed leaving just the fastener in place.

FIGS. 155A-E show another embodiment of a device 15600 configured toapproximate and join materials. FIG. 155A shows a sharpened hollow fang15602 penetrating a first material 15604 and a second material 15606.The materials can be tissue, ADM, mesh, membrane, etc. As shown in FIG.155B, a strand 15608 (e.g., a polymer strand) is advanced out from theend of the fang 15602. FIG. 155C shows the fang 15602 removed, leavingjust the strand 15608 in place penetrating both materials 15604, 15606.In FIG. 155D, a fusing tube or device 15610 is shown advanced over theends or limbs of the strand 15608 and to the repair site. Advancing thedevice 15610 can result in approximating and compressing materials15604, 15606. As shown in FIG. 155E, the strand 15608 is fused into aloop at union point 15612, and the device 15610 is removed.

FIG. 156 shows an embodiment of a device 15700 configured to gripmaterial such as tissue (or ADM, mesh, membrane, etc.) so that the usercan pull the tissue for countertraction when performing variousprocedures (e.g. stapling). Pincers 15702 are located at the end ofinner tube 15704. Pincers 15706 are located at the end of outer tube15708. The tips of the pincers 15702 on the inner tube 15704 pointtowards the tips of the pincers 15706 on the outer tube 15708. The innertube 15704 is rotated one direction (e.g. counterclockwise in FIG. 156 )to open the gap between the outer tube pincers 15706 and inner tubepincers 15702. The pincers 15702, 15706 are placed on the material ortissue of interest, and the inner tube 15704 is rotated the oppositedirection (e.g. clockwise in FIG. 156 ) to close the gap between theouter tube pincers 15706 and inner tube pincers 15702, causing thepincers 15702, 15706 to grip the material. The user can pull on thetubes 15704, 15708 to lift the material or tissue as needed. A surgicaldevice (e.g. stapler or scope) can be inserted down the lumen 15710 ofthe inner tube 15704 to work on the material or tissue (e.g. place astaple). This tissue retraction device can be made with small (micro)pincers or larger pincers. Windows can also be cut in the sides of thetubes to provide visibility and access to the tissue and work site. Thismechanism could be separate from a stapler (or other device) orintegrated into a stapler (or other device).

FIGS. 157A-D show a device 15800 configured to grip material (e.g.,tissue, ADM, mesh, membrane, etc.) so that the user can pull the tissuefor countertraction when performing various procedures (e.g., stapling).Pincers 15802 are positioned within sleeve 15804, as shown in FIG. 157A.The pincers are biased (e.g., spring loaded) outward. The pincers 15802are placed on the tissue of interest. The sleeve 15804 is advanced,causing the pincers 15802 to move toward one another and grip thematerial, as shown in FIG. 157B. The number of pincers could vary, asshown in FIG. 157C (2 pincers) and 157D (6 pincers). Other amounts ofpincers are also possible (e.g., 3, 4, 5, 6, 7, 8, more, etc.).

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements (including steps), these features/elementsshould not be limited by these terms, unless the context indicatesotherwise. These terms may be used to distinguish one feature/elementfrom another feature/element. Thus, a first feature/element discussedbelow could be termed a second feature/element, and similarly, a secondfeature/element discussed below could be termed a first feature/elementwithout departing from the teachings of the present invention.

Throughout this specification and the claims which follow, unless thecontext requires otherwise, the word “comprise”, and variations such as“comprises” and “comprising” means various components can be co jointlyemployed in the methods and articles (e.g., compositions and apparatusesincluding device and methods). For example, the term “comprising” willbe understood to imply the inclusion of any stated elements or steps butnot the exclusion of any other elements or steps.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical valuesgiven herein should also be understood to include about or approximatelythat value, unless the context indicates otherwise. For example, if thevalue “10” is disclosed, then “about 10” is also disclosed. Anynumerical range recited herein is intended to include all sub-rangessubsumed therein. It is also understood that when a value is disclosedthat “less than or equal to” the value, “greater than or equal to thevalue” and possible ranges between values are also disclosed, asappropriately understood by the skilled artisan. For example, if thevalue “X” is disclosed the “less than or equal to X” as well as “greaterthan or equal to X” (e.g., where X is a numerical value) is alsodisclosed. It is also understood that the throughout the application,data is provided in a number of different formats, and that this data,represents endpoints and starting points, and ranges for any combinationof the data points. For example, if a particular data point “10” and aparticular data point “15” are disclosed, it is understood that greaterthan, greater than or equal to, less than, less than or equal to, andequal to 10 and 15 are considered disclosed as well as between 10 and15. It is also understood that each unit between two particular unitsare also disclosed. For example, if 10 and 15 are disclosed, then 11,12, 13, and 14 are also disclosed.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

1. A fastening device comprising: a shaft; a handle; a needle extendingfrom the shaft, the needle comprising a slot extending along at least aportion of the needle, the device configured to receive a fastenercomprising a first bar and a second bar connected by a bar connector,the first bar positioned within the needle and the second bar positionedoutside the needle within the shaft; and a push member configured topush the fastener out of the needle.
 2. The device of claim 1, furthercomprising a fastener positioned such that the first bar is positionedwithin the needle and the second bar is positioned outside the needlewithin the shaft.
 3. The device of claim 1, further comprising afastener reservoir within the shaft, wherein the fastener is configuredto convey down the reservoir.
 4. (canceled)
 5. The device of claim 1,further comprising at least one deflector near a distal end of thedevice, the deflector configured to reorient the second bar while thefastener is pushed distally.
 6. The device of claim 1, furthercomprising a stop positioned at a fixed or adjustable distance proximalto the distal end of the needle and configured to control an insertiondepth of the needle.
 7. The device of claim 1, further comprising atrigger configured to deploy a fastener by engaging the push member.8.-23. (canceled)
 24. The device of claim 1, comprising a firstdeflector extending from a surface on one side of the needle, the firstdeflector extending away from the surface and configured to lift the barconnector and second bar to another side of the needle as the fasteneris being pushed distally.
 25. The device of claim 1, further comprisinga deflector extending towards the needle and configured to rotate thesecond bar as the fastener is being pushed distally, such that thesecond bar is moved towards an orientation approximately parallel to amaterial being fastened.
 26. The device of claim 1, further comprising asurface configured to maintain the rotated position of the second bar.27. (canceled)
 28. (canceled)
 29. (canceled)
 30. (canceled)
 31. Thedevice of claim 1, wherein edges of the needle slot comprise rounded,broken, polished, or other non-sharp edge configurations.
 32. The deviceof claim 1, wherein a size of an inner diameter of the needle and a sizeof an outer diameter of the needle are selected to provide asufficiently sized passageway through the material to be joined so thefastener's bar and bar connector pass through the material to be joinedwith minimal force.
 33. The device of claim 32, wherein the size of theinner diameter and outer diameter of the needle is selected to provideminimal insertion force in the material to be joined.
 34. The device ofclaim 1, wherein a bevel angle of the needle tip is configured toprovide minimal insertion force in the material to be joined.
 35. Thedevice of claim 34, wherein the bevel angle of the needle tip isconfigured to withstand repeated use.
 36. The device of claim 1, whereina length of the needle is selected to minimize trauma to tissue andstructures surrounding a repair site.
 37. The device of claim 1, whereinthe length of the needle is selected to be suitable for depositing oneend or more than one end of the fastener in tissue. 38.-60. (canceled)61. A method for fastening an onlay material to tissue comprising;piercing the onlay material and tissue with a needle comprising a slot,the needle forming part of a fastening device; and advancing a fastenercomprising a first bar positioned within the needle, the first barconnected to a second bar by a connector.
 62. The method of claim 61,further comprising using a stop to control the insertion depth of theneedle.
 63. The method of claim 61, further comprising withdrawing theneedle out of the tissue from a first location in tissue, positioning ortensioning the material on the needle, and piercing the tissue at asecond location.
 64. The method claim 61, further comprising reorientingthe second bar.
 65. The method of claim 61, wherein advancing thefastener comprising activating a deployment mechanism trigger on thefastening device.
 66. The method of claim 61, further comprisingmaintaining/stabilizing the position of the needle within the onlaymaterial and tissue while deploying the fastener.
 67. The method ofclaim 61, wherein reorienting the second bar comprises using one or moredeflectors ramps positioned near a distal end of the device.
 68. Themethod of claim 61, wherein reorienting the second bar comprises movingthe second bar to avoid engaging the slot of the needle.
 69. The methodof claim 61, wherein reorienting the second bar comprises moving thesecond bar towards a position approximately parallel to a surface of theonlay material or tissue.
 70. The method of claim 61, whereinreorienting the second bar comprises rotating the second bar such thatthe second bar moves towards being approximately parallel to the surfaceof the onlay material or tissue.
 71. The method of claim 61, furthercomprising deploying the first bar within the tissue.
 72. The method ofclaim 61, further comprising deploying the second bar such that it restsadjacent to the onlay material.
 73. The method of claim 61, furthercomprising deploying the fastener such that the tissue and onlaymaterial are approximated and fixed together by the fastener.
 74. Themethod of claim 61, further comprising withdrawing the needle from theonlay material and tissue after the fastener is deployed.
 75. The methodof claim 61, further comprising supporting the onlay material and tissuewhile withdrawing the needle. 76.-346. (canceled)
 347. The device ofclaim 1, wherein the slot extends through a distal end of the needle.348. The device of claim 1, wherein the needle comprises a sharp tip.349. A system comprising the device of claim 1 and a fastener comprisinga first bar; a second bar; and a connector joining the first bar to thesecond bar, wherein the connector is configured to be strong enough towithstand deployment of the first bar.
 350. The system of claim 349,wherein at least one of a height, length, or width of the second bar isdifferent from a corresponding dimension of the first bar.
 351. Thesystem of claim 349, wherein at least one of the first and second barhas one or more blunt ends.
 352. The system of claim 349, wherein atleast one of the first bar, the second bar, and the connector comprisesa rectangular cross section.
 353. The method of claim 61, furthercomprising deploying the fastener by advancing the fastener within theneedle and out of the distal end of the needle such that the connectorextends through the slot and exits the slot at the distal end of theneedle.
 354. The method of claim 61, wherein the only material comprisesacellular dermal matrix (ADM).
 355. The method of claim 61, whereinpiercing the onlay material comprises piercing the onlay material with asharp tip of the needle.